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Original Investigation
Caring for the Critically Ill Patient
October 10, 2017

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

Author Affiliations
  • 1Département de Médecine Périopératoire, Université Clermont Auvergne, Centre national de la recherche scientifique, Inserm, Centre Hospitalier Universitaire Clermont-Ferrand, Clermont-Ferrand, France
  • 2Section d’Anesthésie and Département Anesthésie et Réanimation, Centre Hospitalier Universitaire Nîmes, Nîmes, France
  • 3Département Anesthésie et Réanimation, Centre Hospitalier Universitaire Amiens, Amiens, France
  • 4Service Anesthésie et Réanimation, Assistance Publique Hôpitaux de Marseille, Hôpital Nord, Université Aix Marseille, Marseille, France
  • 5Service d’Anesthésie-Réanimation, Université Claude Bernard Lyon-1, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Lyon, France
  • 6Département Anesthésie-Réanimation, Centre Hospitalier Universitaire Saint-Etienne, Saint-Étienne, France
  • 7Service Anesthésie et Réanimation, Assistance Publique Hôpitaux de Marseille, Hôpital de la Conception, Marseille, France
  • 8Anesthésie et Réanimation, Clinique du Parc, Castelnau-Le-Lez, France
  • 9Pôle Anesthésie-Réanimation, Centre Hospitalier Universitaire Lille, Lille, France
  • 10Biostatistic Unit, Centre Hospitalier Universitaire Clermont-Ferrand, Direction de la Recherche Clinique, Clermont-Ferrand, France
  • 11Département Anesthésie et Réanimation B, Centre Hospitalier Universitaire Montpellier, Hôpital Saint-Eloi, and INSERM U-1046, Montpellier, France
JAMA. 2017;318(14):1346-1357. doi:10.1001/jama.2017.14172
Key Points

Question  Does a strategy based on individualized blood pressure management reduce postoperative complications among high-risk patients undergoing major abdominal surgery?

Findings  In this randomized clinical trial involving 292 patients, most of whom underwent abdominal surgery, an individualized management strategy of targeting a systolic blood pressure within 10% of the patient’s normal resting value, compared with standard practice, resulted in significantly lower rates of postoperative organ dysfunction (38.1% vs 51.7%, respectively).

Meaning  Among patients undergoing abdominal surgery, an individualized blood pressure management strategy during surgery tailored to individual patient physiology may improve postoperative outcomes.

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

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