HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients Undergoing Major Abdominal Surgery

Humanitas Clinical and Research Center636 enrolled

Overview

This study is a multicenter randomized controlled trial comparing two strategies of mean arterial blood pressure management (MAP ≥ 80mmHg vs MAP ≥ 65 mmHg) in high-risk surgical patients undergoing elective laparotomic/laparoscopic surgery.

Intraoperative hypotension has been associated with major postoperative complications after non-cardiac surgery. However, is is still unclear the optimal intraoperative mean arterial pressure (MAP) target in the subgroup of those patient with an history of hypertension at home, and at risk of developing postoperative complications. The objective of this study is to assess the effects of an intraoperative blood pressure management strategy aiming at keeping the MAP ≥ 80mmHg), as compared to the conventional practice (to maintain intraoperative MAP ≥ 65mmHg), on a composite outcome considering the death rate and the incidence of major events in patient scheduled for elective laparotomic/laparoscopic surgery. The primary outcome is a composite of 30-days from operation mortality rate and at least one major organ dysfunction including the renal, respiratory, cardiovascular and neurologic systems or new onset of sepsis and septic shock occurring by day 7 after surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

636

Conditions

Blood Pressure Complication,Postoperative Intraoperative Hypotension

Interventions

EphedrineDRUG

In both the group, the target MAP can be maintained by means of bolus of ephedrine (2.5 mg). The maximal dose for the ephedrine allowed is 25 mg (10 boluses of 2.5 mg), after this threshold a continuous infusion of norepinephrine will be started

NorepinephrineDRUG

In both the group, the target MAP can be maintained by means of bolus of ephedrine (2.5 mg) or Etilefrine (1 mg). The continuous infusion of norepinephrine, as decided by the attending anesthetist, may be started at any point of the intraoperative period. The starting dose of norepinephrine is the lowest needed to reach the predefined MAP target.

Etilefrine Hydrochloride bolusDRUG

The maximal dose for the etilefrine allowed is 10 mg (10 boluses of 1 mg), after this threshold a continuous infusion of norepinephrine will be started

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria (all the following) 1. Adult patients ≥ 60 years 2. History of chronic hypertension requiring home therapy. 3. Scheduled for major elective abdominal surgery (laparoscopic, robotic or laparotomic) 4. Expected surgical duration of at least 3 hours. 5. Needing invasive arterial and hemodynamic monitoring as decided by the attending anesthetist, according to the rules of good clinical practice of each involved center. AND At increased risk of postoperative complications (at least one of the following): 1. American Society of Anesthesiologists (ASA) class 3 or 4 2. Known or documented history of coronary artery disease (angina, myocardial infarction or acute coronary syndrome). 3. Known or documented history of peripheral vascular disease. 4. Known or documented history of heart failure requiring treatment. 5. Ejection fraction less than 30% (echocardiography) 6. Signs of diastolic moderate to severe dysfunction or chronic hypertensive cardiomyopathy (echocardiography) 7. Moderate or severe valvular heart disease (echocardiography) 8. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Radiographically confirmed or according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. 9. Diabetes currently treated with an oral hypoglycemic agent and/or insulin 10. Morbid obesity (BMI ≥35 kg/m2) 11. Preoperative serum albumin \<30 g/l 12. Anaerobic threshold (if done) \<14 ml/kg/min 13. Exercise tolerance equivalent to six metabolic equivalents (METs) or less as defined by American College of Cardiology/American Heart Association guidelines Exclusion criteria 1. Refusal of consent 2. Chronic kidney disease with glomerular filtration rate \<30 ml/min/1.73 m2 or requiring renal-replacement therapy for end-stage renal disease 3. Acute cardiovascular event, including acute or decompensated heart failure and acute coronary syndrome (within prior 30 days). 4. Urgent or time-critical surgery 5. Aortic or Renal vascular surgery (including nephrectomy) 6. Liver Surgery 7. Neurosurgery 8. Surgery for palliative treatment only or ASA physical status 5 9. Pregnancy

Locations (18)

Ospedali Riuniti Foggia- Università di Foggia

Foggia, Apulia, Italy

Department of Anesthesia and Intensive Care, University Hospital of Modena

Modena, Emilia-Romagna, Italy

Outcomes

Primary Outcomes

Composite endpoint of postoperative mortality and at least one major organ dysfunction (see description in the secondary outcomes).

Composite postoperative outcome

Time frame: up to 30 days after operation

Secondary Outcomes

Hospital stay (days)

Time frame: up to 30 days after operation

ICU stay (days)

Intensive Care Unit stay (days)

Time frame: up to 30 days after operation

ICU readmission

Intensive Care Unit readmissions

Time frame: up to 30 days after operation

Sequential Organ Failure Assessment (SOFA) scores on postoperative

Postoperative organ failure - SOFA scores ranges from 0 (\<2% of mortality) to 24 (\>90% of mortality)

Time frame: up to 7 days after operation

Overall intraoperative fluid balance

Intraoperative infusions (crystalloids, colloids, blood products) / Intraoperative loss balance (urine output)

Time frame: day 1 after the operation

Mortality

Time frame: up to 30 days after operation

Vasopressors use

Dose and timing of vasoactive drug infusion intraoperatively

Time frame: day 1 after the operation

Data from ClinicalTrials.gov

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