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JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.

Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial.

Author information

1
Département de Médecine Périopératoire, Université Clermont Auvergne, Centre national de la recherche scientifique, Inserm, Centre Hospitalier Universitaire Clermont-Ferrand, Clermont-Ferrand, France.
2
Section d'Anesthésie and Département Anesthésie et Réanimation, Centre Hospitalier Universitaire Nîmes, Nîmes, France.
3
Département Anesthésie et Réanimation, Centre Hospitalier Universitaire Amiens, Amiens, France.
4
Service Anesthésie et Réanimation, Assistance Publique Hôpitaux de Marseille, Hôpital Nord, Université Aix Marseille, Marseille, France.
5
Service d'Anesthésie-Réanimation, Université Claude Bernard Lyon-1, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Lyon, France.
6
Département Anesthésie-Réanimation, Centre Hospitalier Universitaire Saint-Etienne, Saint-Étienne, France.
7
Service Anesthésie et Réanimation, Assistance Publique Hôpitaux de Marseille, Hôpital de la Conception, Marseille, France.
8
Anesthésie et Réanimation, Clinique du Parc, Castelnau-Le-Lez, France.
9
Pôle Anesthésie-Réanimation, Centre Hospitalier Universitaire Lille, Lille, France.
10
Biostatistic Unit, Centre Hospitalier Universitaire Clermont-Ferrand, Direction de la Recherche Clinique, Clermont-Ferrand, France.
11
Département Anesthésie et Réanimation B, Centre Hospitalier Universitaire Montpellier, Hôpital Saint-Eloi, and INSERM U-1046, Montpellier, France.

Abstract

Importance:

Perioperative hypotension is associated with an increase in postoperative morbidity and mortality, but the appropriate management strategy remains uncertain.

Objective:

To evaluate whether an individualized blood pressure management strategy tailored to individual patient physiology could reduce postoperative organ dysfunction.

Design, Setting, and Participants:

The Intraoperative Norepinephrine to Control Arterial Pressure (INPRESS) study was a multicenter, randomized, parallel-group clinical trial conducted in 9 French university and nonuniversity hospitals. Adult patients (n = 298) at increased risk of postoperative complications with a preoperative acute kidney injury risk index of class III or higher (indicating moderate to high risk of postoperative kidney injury) undergoing major surgery lasting 2 hours or longer under general anesthesia were enrolled from December 4, 2012, through August 28, 2016 (last follow-up, September 28, 2016).

Interventions:

Individualized management strategy aimed at achieving a systolic blood pressure (SBP) within 10% of the reference value (ie, patient's resting SBP) or standard management strategy of treating SBP less than 80 mm Hg or lower than 40% from the reference value during and for 4 hours following surgery.

Main Outcomes and Measures:

The primary outcome was a composite of systemic inflammatory response syndrome and dysfunction of at least 1 organ system of the renal, respiratory, cardiovascular, coagulation, and neurologic systems by day 7 after surgery. Secondary outcomes included the individual components of the primary outcome, durations of ICU and hospital stay, adverse events, and all-cause mortality at 30 days after surgery.

Results:

Among 298 patients who were randomized, 292 patients completed the trial (mean [SD] age, 70 [7] years; 44 [15.1%] women) and were included in the modified intention-to-treat analysis. The primary outcome event occurred in 56 of 147 patients (38.1%) assigned to the individualized treatment strategy vs 75 of 145 patients (51.7%) assigned to the standard treatment strategy (relative risk, 0.73; 95% CI, 0.56 to 0.94; P = .02; absolute risk difference, -14%, 95% CI, -25% to -2%). Sixty-eight patients (46.3%) in the individualized treatment group and 92 (63.4%) in the standard treatment group had postoperative organ dysfunction by day 30 (adjusted hazard ratio, 0.66; 95% CI, 0.52 to 0.84; P = .001). There were no significant between-group differences in severe adverse events or 30-day mortality.

Conclusions and Relevance:

Among patients predominantly undergoing abdominal surgery who were at increased postoperative risk, management targeting an individualized systolic blood pressure, compared with standard management, reduced the risk of postoperative organ dysfunction.

Trial Registration:

clinicaltrials.gov Identifier: NCT01536470.

PMID:
28973220
PMCID:
PMC5710560
DOI:
10.1001/jama.2017.14172
[Indexed for MEDLINE]
Free PMC Article

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