Format

Send to

Choose Destination
JAMA. 2014 Dec 3;312(21):2254-64. doi: 10.1001/jama.2014.15284.

Perioperative aspirin and clonidine and risk of acute kidney injury: a randomized clinical trial.

Collaborators (151)

Alvarez A, Bulach R, Hannon S, Ives K, Jeffreys A, Lang S, Ludbrook G, Myles P, Osborne C, Painter T, Riedel B, Sawhney S, Sivalingam P, Fleischmann E, Kabon B, Luf F, Radonic M, Bidgoli S, De Hert S, De Kock M, Hublet S, Van der Linden P, Forget P, Bergo R, Berwanger O, Duarte P, Gualandro D, Abbas S, Allard R, Beattie W, Chan V, Chauret D, Chin K, Cook D, Dechert W, de Medicis E, Dresser G, Dumerton-Shore D, El Beheiry H, Garg A, Graham M, Gregus K, Gros M, Hornstein D, Jackson P, Jones P, Lavi R, Lawrence K, Li P, McCourt J, McMullen S, Mizera R, Moor R, Ong D, Parlow J, Raazi M, Regalado O, Schricker T, Schumann V, Shin J, Srinathan S, Tiboni M, Todd A, VanHelder T, Wijeysundera D, Jara X, Leon P, Torres D, Cortes O, Montes F, Parra G, Rojas M, Plata R, Romero F, Vasquez S, Villar J, Bauer N, Bøgeskov M, Dahl R, Madsen M, Martinsen K, Søndergaard E, Alfonsi P, Coriat P, Diemunsch P, Piriou V, Hoeft A, Kaisers U, Treschan T, Chan M, Choi G, Gin T, Chiu P, Abraham V, Agarwal K, Gaikwad S, Mehra B, Mohan N, Premendaran B, Sidhu G, Lembo R, Pasin L, Passarani S, Lee H, Jamieson K, Olliff S, Walker S, Amir M, Ishtiaq O, Safdar J, Acuna-Villaorduna A, Barrionuevo P, Castaneda-Guarderas A, Biccard B, Diedericks B, Drummond L, Naidoo P, Alvarez J, de Nadal M, del Valle S, Gonzalez R, González-Suárez S, González-Tallada A, Maestre M, Mena E, Plou P, Tena B, Sabate S, Urrutia G, Balaji P, Hemmings N, Vizcaychipi M, Wrench I, Ai D, Arora H, Bergese S, Cata J, Coombs R, Honar H, Kumar P, Kurz A, Martinelli S, McKay R, Melibary S, Memtsoudis S, Miller S, Nemergut E, Podolyak A, Salmasi V, Sessler D, Uribe A.

Author information

1
London Health Sciences Centre and Western University, London, Ontario, Canada.
2
Cleveland Clinic, Cleveland, Ohio.
3
McMaster University, Hamilton Health Sciences Centre, St Joseph's Healthcare and the Population Health Research Institute, Hamilton, Ontario, Canada.
4
Yale University School of Medicine, New Haven, Connecticut.
5
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
6
Fundación Oftalmológica de Santander, Bucaramanga, Colombia.
7
Herlev Hospital and the University of Copenhagen, Copenhagen, Denmark.
8
Chinese University of Hong Kong, Hong Kong Special Administrative Region, China.
9
Clinica Santa Maria, Universidad de los Andes, Santiago, Chile.
10
Kingston General Hospital, Kingston, Ontario, Canada.
11
Hospital Vall d'Hebron, Barcelona, Spain.
12
Shifa International Hospitals Limited, Islamabad, Pakistan.
13
CHU Brugmann, Brussels, Belgium.
14
San Raffaele Scientific Institute, Milan, Italy.
15
Vejle Hospital, Vejle, Denmark.
16
Hospital Nacional Cayetano Heredia, Lima, Peru.
17
Monash University, Melbourne, Australia.
18
University of North Carolina Medical School, Chapel Hill.
19
Vienna General Hospital and the Medical University of Vienna, Vienna, Austria.
20
Fundación Cardioinfantil and the Universidad Autónoma de Bucaramanga, Bogotá, Colombia.
21
Royal Adelaide Hospital, Adelaide, Australia.
22
Nelson R. Mandela School of Medicine, Durban, South Africa.
23
Ohio State University Medical Center, Columbus.
24
University of Manitoba, Winnipeg, Canada.
25
University of Texas and MD Anderson Cancer Center, Houston.
26
University Health Network and the University of Toronto, Toronto, Ontario, Canada.
27
Mahatma Gandhi Institute of Medical Sciences, Wardha, India.
28
Royal Melbourne Hospital, Melbourne, Australia.
29
Cliniques Universitaires Saint-Luc and the Université Catholique de Louvain, Brussels, Belgium.

Abstract

IMPORTANCE:

Acute kidney injury, a common complication of surgery, is associated with poor outcomes and high health care costs. Some studies suggest aspirin or clonidine administered during the perioperative period reduces the risk of acute kidney injury; however, these effects are uncertain and each intervention has the potential for harm.

OBJECTIVE:

To determine whether aspirin compared with placebo, and clonidine compared with placebo, alters the risk of perioperative acute kidney injury.

DESIGN, SETTING, AND PARTICIPANTS:

A 2 × 2 factorial randomized, blinded, clinical trial of 6905 patients undergoing noncardiac surgery from 88 centers in 22 countries with consecutive patients enrolled between January 2011 and December 2013.

INTERVENTIONS:

Patients were assigned to take aspirin (200 mg) or placebo 2 to 4 hours before surgery and then aspirin (100 mg) or placebo daily up to 30 days after surgery, and were assigned to take oral clonidine (0.2 mg) or placebo 2 to 4 hours before surgery, and then a transdermal clonidine patch (which provided clonidine at 0.2 mg/d) or placebo patch that remained until 72 hours after surgery.

MAIN OUTCOMES AND MEASURES:

Acute kidney injury was primarily defined as an increase in serum creatinine concentration from the preoperative concentration by either an increase of 0.3 mg/dL or greater (≥26.5 μmol/L) within 48 hours of surgery or an increase of 50% or greater within 7 days of surgery.

RESULTS:

Aspirin (n = 3443) vs placebo (n = 3462) did not alter the risk of acute kidney injury (13.4% vs 12.3%, respectively; adjusted relative risk, 1.10; 95% CI, 0.96-1.25). Clonidine (n = 3453) vs placebo (n = 3452) did not alter the risk of acute kidney injury (13.0% vs 12.7%, respectively; adjusted relative risk, 1.03; 95% CI, 0.90-1.18). Aspirin increased the risk of major bleeding. In a post hoc analysis, major bleeding was associated with a greater risk of subsequent acute kidney injury (23.3% when bleeding was present vs 12.3% when bleeding was absent; adjusted hazard ratio, 2.20; 95% CI, 1.72-2.83). Similarly, clonidine increased the risk of clinically important hypotension. In a post hoc analysis, clinically important hypotension was associated with a greater risk of subsequent acute kidney injury (14.3% when hypotension was present vs 11.8% when hypotension was absent; adjusted hazard ratio, 1.34; 95% CI, 1.14-1.58).

CONCLUSIONS AND RELEVANCE:

Among patients undergoing major noncardiac surgery, neither aspirin nor clonidine administered perioperatively reduced the risk of acute kidney injury.

TRIAL REGISTRATION:

clinicaltrials.gov Identifier: NCT01082874.

PMID:
25399007
DOI:
10.1001/jama.2014.15284
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Silverchair Information Systems
Loading ...
Support Center