Individualized Blood Pressure Management in Patients Undergoing Cardiac Surgery

NCT03784690 | Withdrawn DMC

• 1 other identifier: 19
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot randomized-controlled study will determine the feasibility of large study comparing individualized versus standard blood pressure (BP) management in patients undergoing cardiac surgery under cardiopulmonary bypass (CPB). Our hypothesis is that maintaining higher BP levels based on preoperative measurements will reduce the incidence of major complications (composite outcome).

Conditions

Cardiac Surgery

Keywords

Hypotension; Intraoperative blood pressure; Cardiopulmonary bypass; Myocardial infarction; Acute kidney injury

Outcome Measures

Primary Outcomes (2)

• Compliance with the protocol

  Successful compliance with protocol is defined as ≥ 90% of prescribed intervention being administered across all patients.

  Operative day 1

• Successful recruitment rate

  Successful recruitment rate will be defined as recruitment of 2 patients per week.

  12 month

Secondary Outcomes (13)

• Postoperative creatinine concentration

  3 days after surgery

• Postoperative cardiac troponin I level

  12 hours after surgery

• Intraoperative blood pressure

  Operative day 1

• Rate of postoperative complications

  30 days after surgery

• Postoperative blood loss

  Postoperative day 1

Study Arms (2)

Individualized BP group

EXPERIMENTAL

Individualized intraoperative BP management

Other: Individualized intraoperative BP management

Standard treatment group

PLACEBO COMPARATOR

Standard intraoperative BP management

Other: Standard intraoperative BP management

Interventions

Individualized intraoperative BP management OTHER

In the treatment group, the nurse will measure resting blood pressure three times in the ward one day before surgery (after a 5-min rest while lying supine). Average measurement will be used to calculate mean arterial pressure (MAP). Before and after CPB patients will receive continuous infusion of norepinephrine to maintain MAP within ± 10% of patients resting MAP. If targeted MAP during CPB could not be achieved after increasing pump-flow (not more than 130%), infusion of norepinephrine will used. After CPB, the choice of vasopressors/inotropes to maintain predefined MAP will be left on attending anesthesiologists based on patient status.

Individualized BP group

Standard intraoperative BP management OTHER

Standard treatment strategy will be used aiming to maintain pre-bypass and post-bypass MAP at 65-75 mm Hg. MAP during CPB will be maintained at 50-60 mm Hg. If MAP of 50-60 mm Hg during CPB could not be achieved after increasing pump-flow (not more than 130%), infusion of norepinephrine will be started. No vasodilators will be used if MAP will exceed predefined range.

Standard treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• Signed informed consent
• Elective cardiac surgery under CPB (CABG or valve surgery)

You may not qualify if:

• Unstable Coronary Artery Disease: Recent (\< 6 weeks) myocardial infarction, unstable angina, severe (\> 70%) left main coronary artery stenosis
• Uncontrolled hypertension preoperatively (SBP \> 160 mm Hg)
• Critical preoperative state (ventricular tachycardia or ventricular fibrillation or aborted sudden death, preoperative cardiac massage, preoperative ventilation before anesthetic room, hemodynamic instability, preoperative inotropes or intraaortic balloon pumping, preoperative severe acute renal failure (anuria or oliguria \<10ml/hr)
• Planned surgery on aorta
• Emergency surgery
• Pregnancy
• Current enrollment into another randomized controlled trial (in the last 30 days)
• Previous enrollment and randomization into current study
• Glomerular filtration rate ≤59 ml/min/1.73m2 (Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation)

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

Meshalkin Research Institute of Pathology of Circulation

Novosibirsk, 630055, Russia

Location

Related Publications (6)

• Sessler DI, Khanna AK. Perioperative myocardial injury and the contribution of hypotension. Intensive Care Med. 2018 Jun;44(6):811-822. doi: 10.1007/s00134-018-5224-7. Epub 2018 Jun 4.

  PMID: 29868971 BACKGROUND

• Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.

  PMID: 23835589 BACKGROUND

• Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E.

  PMID: 15616043 BACKGROUND

• Bijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KG, Kalkman CJ. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009 Dec;111(6):1217-26. doi: 10.1097/ALN.0b013e3181c14930.

  PMID: 19934864 BACKGROUND

• Sun LY, Chung AM, Farkouh ME, van Diepen S, Weinberger J, Bourke M, Ruel M. Defining an Intraoperative Hypotension Threshold in Association with Stroke in Cardiac Surgery. Anesthesiology. 2018 Sep;129(3):440-447. doi: 10.1097/ALN.0000000000002298.

  PMID: 29889106 BACKGROUND

• Gold JP, Charlson ME, Williams-Russo P, Szatrowski TP, Peterson JC, Pirraglia PA, Hartman GS, Yao FS, Hollenberg JP, Barbut D, et al. Improvement of outcomes after coronary artery bypass. A randomized trial comparing intraoperative high versus low mean arterial pressure. J Thorac Cardiovasc Surg. 1995 Nov;110(5):1302-11; discussion 1311-4. doi: 10.1016/S0022-5223(95)70053-6.

  PMID: 7475182 BACKGROUND

MeSH Terms

Conditions

Hypotension; Myocardial Infarction; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Vladimir Lomivorotov, MD, PhD

  Meshalkin Research Institute of Pathology of Circulation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: December 24, 2018
• Study Start: January 21, 2019
• Primary Completion: March 10, 2020
• Study Completion: April 10, 2020
• Last Updated: November 22, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)