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Neutropenic Sepsis: Prevention and Management of Neutropenic Sepsis in Cancer Patients

The purpose of this guideline is to ensure prompt and effective management of cancer patients presenting with neutropenic sepsis, as well as advising on prevention and diagnosis of this important complication of anticancer treatments. It is a significant cause of mortality and morbidity and causes delays and dose reductions to planned treatment. The greatest risk of neutropenic sepsis is with cytotoxic chemotherapy. The Guideline Development Group (GDG) recognises the importance of distinguishing uncomplicated neutropenic fever from neutropenia with severe sepsis and shock, and indeed septic shock can occur without fever. In clinical practice the terms febrile neutropenia and neutropenic sepsis are used interchangeably in this patient group and recommendations within this guideline use the term “neutropenic sepsis” to indicate the full range of severity of illness.

NICE Clinical Guidelines - National Collaborating Centre for Cancer (UK).

Version: September 2012

Adjustment of antimicrobial agents for adults with sepsis, severe sepsis or septic shock

Broad‐spectrum antimicrobial treatment is defined as the use of an antibiotic or a combination of antibiotics which act against a wide range of disease‐causing bacteria. Broad‐spectrum antimicrobial treatment can reduce mortality rates in patients with sepsis, severe sepsis or septic shock. Sepsis is a serious medical condition which is characterized by an inflammatory response to an infection that can affect the whole body. The patient may develop this inflammatory response to microbes in their blood, urine, lungs, skin or other tissues. However, there is a risk that empirical broad‐spectrum antimicrobial treatment can expose patients to overuse of antimicrobials and increase the resistance of micro‐organisms to treatment. De‐escalation has been proposed as a means of adjusting initial, adequate broad‐spectrum treatment by changing the antimicrobial agent or discontinuing an antimicrobial combination according to the patient's culture results (a means of identifying the microbe causing the infection). In this updated Cochrane review we searched the databases until October 2012. We found no published randomized controlled trials (RCTs). We found one ongoing RCT. There is no adequate or direct evidence on whether de‐escalation of antimicrobial agents is effective and safe for adults with sepsis, severe sepsis or septic shock. Appropriate studies are needed to investigate the potential benefits proposed by de‐escalation treatment.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

Antibiotic regimens for suspected early neonatal sepsis

Antibiotics for newborn infants that might have blood infections when aged less than 48 hours. Blood infection (sepsis) can make newborn infants seriously ill or even kill them. Sepsis in newborns less than 48 hours old is called early neonatal sepsis. It is usually caused by bacteria passed from the mother. Doctors often give antibiotics if they suspect this dangerous condition because it can be difficult to tell if a newborn has early neonatal sepsis. Certain antibiotics can have significant side effects and their use can also lead to antibiotic resistance, which results in worse infection and possible damage to the intestines, kidneys, liver, or hearing. The authors of this review studied the medical literature to find out which kinds of antibiotics are best for suspected early neonatal sepsis, and what side effects these antibiotics cause. They found 15 relevant studies, but only two of these studies focused on infants less than 48 hours old. The two studies included a total of 127 newborns and compared newborns who received one antibiotic (monotherapy) to infants who received more than one antibiotic (combination therapy). There were no differences between the two groups. Both of the studies were published in the 1980s and are probably out of date. The authors of this review concluded that there is no evidence for using a particular kind of antibiotic for early neonatal sepsis.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

Antibiotic regimens for suspected late onset sepsis in newborn infants

Antibiotics for newborn infants that might have blood infections when more than 48 hours old. Blood infection (sepsis) can make newborn infants seriously ill or even kill them. Sepsis in newborns more than 48 hours old is called late onset neonatal sepsis; it is usually caused by bacteria, and sometimes by fungal infection. Doctors often give antibiotics if they suspect this dangerous condition as it can be difficult to tell if a newborn has late onset neonatal sepsis. Certain antibiotics given for this condition can have serious side effects, including antibiotic resistance, which can result in worse infection. This Cochrane review examined which antibiotics are best for treating late onset neonatal sepsis, in terms of effectiveness and side effects. The authors searched the medical literature and found only one study that met all the criteria the authors were looking for. This study, from 1988, enrolled 28 newborn infants. Some of the newborns received a beta lactam antibiotic by itself while others got the beta lactam plus another antibiotic, an aminoglycoside. There were no significant differences between the two kinds of antibiotic treatment in this study. The Cochrane review authors concluded that there is not enough research to recommend one kind of antibiotic treatment over another for late onset neonatal sepsis.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

High‐volume haemofiltration for sepsis

Severe sepsis and septic shock are among the most common causes of death in adults who are sufficiently ill to be admitted to an intensive care unit (ICU). Sepsis often arises following an infection. The organisms causing the infection can be bacterial, viral or fungal. If sepsis develops, the body responds by producing chemicals which cause massive inflammation in the whole body. (Inflammation is how body tissues react to infection, irritation or other injury). This inflammation can cause individual organs to fail e.g. the kidneys, heart, circulation and lungs. It is these organ failures, as a result of the inflammation, which lead to the high death rates associated with sepsis.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

Intravenous immunoglobulins for treating patients with severe sepsis and septic shock

Sepsis is the inflammatory response of the body to severe infection, which can be caused by a variety of micro‐organisms including bacteria, viruses and fungi. Signs of sepsis include fever, hypothermia, rapid heart rate and respiration; and a laboratory finding of increased or decreased white blood cell count. Deaths as a result of sepsis and septic shock remain high despite giving antibiotics, especially if the functions of a persons's vital organs such as the lungs, heart and kidneys are affected. Several studies have looked into other agents than antibiotics to help the body fight the effects of sepsis. Intravenous immunoglobulin preparations contain antibodies that help the body to neutralize bacterial toxins. There are two types of preparations. These are polyclonal immunoglobulins that contain several antibodies directed at endotoxin and inflammatory mediators, and monoclonal immunoglobulins which target a specific inflammatory mediator or antigen. Intravenous immunoglobulins are blood products, specifically pooled sera derived from human donor blood.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

Oral lactoferrin for prevention of sepsis and necrotizing enterocolitis in preterm infants

Premature babies are at risk for blood infection (sepsis) and/or gastrointestinal injury (necrotizing enterocolitis, or NEC). A number of babies with sepsis or NEC die or develop long‐term brain and lung injury despite treatment with antibiotics. Lactoferrin, which is present in human milk, has been shown to be effective against infection when tested in animals and in the laboratory. Lactoferrin also enhances the ability of babies to fight infection. We found four studies that enrolled 1103 preterm babies. Evidence of moderate to low quality suggests that oral lactoferrin with or without a probiotic decreases sepsis and NEC in preterm infants with no adverse effects. When given alone, lactoferrin decreases deaths among preterm infants. We also found large studies that are ongoing, and their results when available may increase the strength of our analysis. Clarification regarding dosing, duration, type of lactoferrin (human or bovine), and development of preterm babies is still needed.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2015

Oral lactoferrin for the treatment of sepsis and necrotizing enterocolitis in neonates

Newborn babies, especially those born prematurely, are at risk from infections in the blood (sepsis) and/or gastrointestinal inflammation and injury (necrotizing enterocolitis). A number of babies with sepsis or necrotizing enterocolitis die or suffer from long‐term brain and lung damage in spite of treatment with antibiotics. Lactoferrin, a substance normally present in human milk, may be effective against infections and gastrointestinal injury. This review searched for studies that used lactoferrin to treat babies with infection or gastrointestinal injury and found none. In view of the potential usefulness of lactoferrin, we recommend that well designed studies be done in the future to address this issue.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2011

Recombinant human activated protein for severe sepsis in neonates

Sepsis (a generalized blood stream infection) is common in neonates. Severe sepsis carries a high mortality and morbidity even with current critical care management. Activated Protein C (APC) is a protein formed within the human body to prevent formation of blood clots and helps in breaking down clots. Recombinant human APC (rhAPC) is a synthesized version of APC using recombinant technology. It has been shown to reduce mortality in severe sepsis in adults. The review authors investigated whether treatment of severe sepsis in newborn infants with rhAPC will help to reduce mortality and severe morbidity. The review authors found no controlled studies in this age group. On October 25, 2011 rhAPC (Xigris®) was withdrawn from the market by Eli Lilly due to side effect in adults. RhAPC should no longer be used in any age category and the product should be returned to the distributor.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

Vancomycin for prophylaxis against sepsis in preterm neonates

Premature babies have immature immune systems and frequently pick up harmful infections in the hospital. This means they are at high risk of sepsis (life‐threatening bacterial infection). The most common bacteria causing sepsis in neonatal intensive care are coagulase negative staphylococci (CoNS). One way of trying to prevent CoNS infection is by infusing low doses of the antibiotic vancomycin (giving the drug by intermittent infusion or continuous drip). The review of trials found that low dose continuous infusions, or low dose intermittent administration, of vancomycin reduce the risk of a baby getting sepsis in the neonatal intensive care unit. There is not enough evidence to show if this approach increases antibiotic resistance in nurseries.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

Granulocyte transfusions for neonates with confirmed or suspected sepsis and neutropenia

More evidence is needed on the effects of granulocyte infusions for babies with sepsis and neutropenia (decreased number of white blood cells). Sepsis is an infection of the blood, caused by bacteria or fungi reaching the bloodstream. It is often fatal when it occurs in newborn babies, especially those born preterm (before 37 weeks). Preterm babies are not yet able to adequately form granulocytes, which are a key part of the immune system's ability to fight infections. Some babies with sepsis, therefore, develop neutropenia (decrease in white blood cells), which makes them more vulnerable. Granulocytes can be infused. However, the review found that there are not enough trials to show the potential benefits or harms of this treatment for newborn babies with sepsis and neutropenia.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2011

To assess the optimal of timing of administering antibiotics to sepsis patients in the emergency department

Sepsis is a serious medical condition characterized by an inflammatory response to an infection that can affect the whole body. The patient may develop an inflammatory response to microbes in their blood, urine, lungs, skin, or other tissues. Sepsis is a serious condition with a very high death rate if left untreated. Most sepsis patients require antibiotics and admission to an intensive care unit (ICU). How soon broad spectrum antibiotics should be delivered is as yet unclear. Broad spectrum antimicrobial treatment is defined as a combination of antibiotics which act against a wide range of disease‐causing bacteria, used to reduce mortality rates in patients with sepsis, severe sepsis or septic shock. We carried out a systematic review of the literature by searching key databases for high quality published and unpublished material on the timing of antibiotics in the emergency department prior to ICU admission. Our searches revealed no randomized controlled trials (RCTs) on the timing of broad spectrum antibiotic treatment in this population. We conclude that there is a need to carry out observational cohort studies, in the absence of RCTs, even if they lack the precision of RCTs. We also conclude that the earlier the antibiotics are administered the better. It is important to realize that the clock starts ticking when the patient arrives in the ED and stops once the antibiotic is started. The pre‐intensive care unit period is the time spent in the ward or ED prior to being admitted to the ICU, where most patients with severe sepsis are admitted. The review was purposefully very specific as it is focused only on patients with severe sepsis and in finding only RCTs. The absence of these may imply, in itself, the complicated nature of the study question as it may be ethically wrong to randomize such patients to a seemingly inferior treatment arm.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

Intravenous N‐acetylcysteine compared to placebo for treatment of systemic inflammatory response syndrome and sepsis in seriously ill adults

Systemic inflammatory response syndrome (SIRS) is a complex response to an insult such as major surgery or trauma. It is called sepsis syndrome, or simply sepsis, when infection is present. The generalized inflammatory reaction involves activation of leukocytes and endothelial cells and the release of inflammatory mediators and toxic oxygen free radicals. Diffuse microthrombosis can result in localized tissue perfusion abnormalities and low oxygenation (hypoxia). Both SIRS and sepsis can be difficult to treat and are major causes of multiple organ failure and the death of patients in the intensive care unit. SIRS and sepsis both lead to a drop in the level of antioxidants normally present in the body.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

Pentoxifylline for treatment of sepsis and necrotizing enterocolitis in neonates

Sepsis is a bacterial or fungal infection of the blood. NEC is a condition with gastrointestinal tract injury and infection seen in premature babies. Modifying the body's response (inflammation) to infection may decrease deaths and tissue injury after sepsis or NEC. Pentoxifylline is a drug that decreases inflammation and possibly tissue injury. We reviewed the effects of pentoxifylline in newborn sepsis and NEC.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2015

Human recombinant activated protein C for severe sepsis and septic shock in adult and paediatric patients

Sepsis and septic shock are major causes of death. Sepsis is a complex syndrome resulting from a presumed or known infection, and its pathogenesis involves interactions between inflammation and blood clotting pathways. This serious medical condition is characterized by an inflammatory response to an infection which can affect the whole body. Patients with sepsis may have developed the inflammatory response because of microbes in their blood, urine, lungs, skin, or other tissues. Severe sepsis can lead to multiple organ failure due to blood clotting in the finer blood vessels. This reduces the amount of blood reaching the organs and septic shock ensues. Protein C reduces the clotting process and a lack of protein C can lead to an exaggeration of blood clotting. Sepsis and septic shock decrease protein C levels in the body. It has been suggested that human recombinant activated protein C (APC) will increase the levels of protein C and ameliorate or prevent multiple organ failure. In this updated Cochrane review we searched the databases until June 2012. We included six randomized clinical trials which involved 6781 people (6307 adult and 474 paediatric participants) with either a high or low risk of death. All trials had high risk of bias and were sponsored by the pharmaceutical industry (Eli Lilly). We found no evidence suggesting that APC reduced the risk of death in adults or children with severe sepsis or septic shock. On the contrary, APC increased the risk of serious bleeding.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

Umbilical cord antiseptics for preventing sepsis and death among newborns

The umbilical cord connects the baby and mother during pregnancy. The cord is cut after birth. The cord stump then dries and falls off, generally within five to 15 days. Infection of the umbilical cord stump (omphalitis), caused by skin bacteria, is a significant cause of illness and death in newborn babies in developing countries. This review evaluated all studies that assessed antiseptics applied topically to the umbilical cord to determine if they reduce the risk of cord infection and death. Thirty‐four randomised controlled studies were included involving 69,338 babies. There were 22 different interventions studied. The most commonly studied antiseptics in the included studies were 70% alcohol, triple dye and chlorhexidine. Three studies were conducted in community settings in developing countries; the remainder were conducted in hospital settings, mostly in developed countries. Studies conducted in community settings were large and contributed about 78% of all the participants included in this review. Hospital‐based studies were small and had limitations.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2015

An Evaluation of the Feasibility, Cost and Value of Information of a Multicentre Randomised Controlled Trial of Intravenous Immunoglobulin for Sepsis (Severe Sepsis and Septic Shock): Incorporating a Systematic Review, Meta-Analysis and Value of Information Analysis

Sepsis is a syndrome characterised by a systemic inflammatory response to infection that leads to rapid acute organ failure and potentially rapid decline to death. Intravenous immunoglobulin (IVIG), a blood product derived from human donor blood, has been proposed as an adjuvant therapy for sepsis.

Health Technology Assessment - NIHR Journals Library.

Version: February 2012
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An evaluation of the feasibility, cost and value of information of a multicentre randomised controlled trial of intravenous immunoglobulin for sepsis (severe sepsis and septic shock): incorporating a systematic review, meta-analysis and value of information analysis

Sepsis is a syndrome characterised by a systemic inflammatory response to infection that leads to rapid acute organ failure and potentially rapid decline to death. Estimates of severe sepsis (sepsis associated with acute organ dysfunction) in UK adult critical-care units from the Intensive Care National Audit & Research Centre Case Mix Programme Database indicate an increasing incidence of severe sepsis in critical care (rising from 50 to 70 cases per 100,000 population per year over the last decade). This now represents approximately 31,000 patient episodes and 15,000 in-hospital deaths per year.

NIHR Health Technology Assessment programme: Executive Summaries - NIHR Journals Library.

Version: 2012

Clinical effectiveness and cost-effectiveness of drotrecogin alfa (activated) (Xigris®) for the treatment of severe sepsis in adults: a systematic review and economic evaluation

Severe sepsis and septic shock are life-threatening systemic responses to infection and are the most common cause of death in intensive care units. The incidence of severe sepsis in the first 24 hours in intensive care in the UK is estimated to be 27.1%, equivalent to 21,191 cases in England and Wales per annum. Despite successful early resuscitation, overall 20-56% of patients with severe sepsis will die from their disease.

NIHR Health Technology Assessment programme: Executive Summaries - NIHR Journals Library.

Version: 2005

Bacterial Meningitis and Meningococcal Septicaemia: Management of Bacterial Meningitis and Meningococcal Septicaemia in Children and Young People Younger than 16 Years in Primary and Secondary Care

This guideline covers bacterial meningitis and meningococcal septicaemia, focusing on management of these conditions in children and young people aged younger than 16 years in primary and secondary care, and using evidence of direct relevance to these age groups where available.

NICE Clinical Guidelines - National Collaborating Centre for Women's and Children's Health (UK).

Version: 2010
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