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Cardiac SurgeryPRECISENCT03784690

Individualized Blood Pressure Management in Patients Undergoing Cardiac Surgery

A study testing Individualized intraoperative BP management and Standard intraoperative BP management in people with Cardiac Surgery, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Surgery
What is being tested?
Individualized intraoperative BP management and Standard intraoperative BP management
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteRussia
Study dates
21 Jan 2019to 10 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Meshalkin Research Institute of Pathology of Circulation

    Novosibirsk, 630055

Other trials in Russia

About this study

Official title: Individualized Blood Pressure Management in Patients Undergoing Cardiac Surgery. A Pilot, Randomized Controlled Study

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).

Read the detailed description

Adequate hemodynamic control is a cornerstone in management in patients undergoing different types of surgery. Among all perioperative risk factors, the association between perioperative hypotension and adverse clinical outcomes in noncardiac and cardiac surgery patients is well defined.

Numerous factors are responsible for development of perioperative hypotension. They include but not limited to perioperative use of renin-angiotensin-aldosterone system and calcium channel blockers, hypovolemia, hemodilution, bleeding and inflammatory response syndrome.

To date, several evidence has been accumulated indicating that intraoperational hypertension can be hazardous.

It was shown that even short durations (1 to 5 min) of an intraoperative mean arterial pressure < 55 mmHg were associated with myocardial injuries and acute kidney injury (AKI).

Results of recent large retrospective cohort study conducted in adult patients who underwent cardiac surgery requiring CPB showed that postoperative stroke was strongly associated with sustained mean arterial pressure of less than 64 mmHg during cardiopulmonary bypass.

In patients undergoing CABG the overall incidence of combined cardiac and neurologic complications was significantly lower in the group where MAP during CPB was relatively high (80-110 mmHg) than in the low pressure group (MAP 50-60 mmHg) (p = 0.026). For each of the individual outcomes the trend favored the high pressure group.

Therefore, MAP may be an important intraoperative therapeutic hemodynamic target to reduce the incidence of complications in patients undergoing CPB.

Conditions
Cardiac Surgery
Being tested
Individualized intraoperative BP management, Standard intraoperative BP management
Keywords
Hypotension, Intraoperative blood pressure, Cardiopulmonary bypass, Myocardial infarction, Acute kidney injury
Medical subject headings
Hypotension, Myocardial Infarction, Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individualized intraoperative BP managementOther

    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.

  • Standard intraoperative BP managementOther

    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.

Study groups in NCT03784690
Study groupRoleWhat they receive
Individualized BP groupExperimentalIndividualized intraoperative BP management
Receives: Other: Individualized intraoperative BP management
Standard treatment groupPlacebo comparatorStandard intraoperative BP management
Receives: Other: Standard intraoperative BP management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compliance with the protocol

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

    Measured: Operative day 1

  2. Successful recruitment rate

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

    Measured: 12 month

Secondary outcomes (13)

  1. Postoperative creatinine concentration

    Plasma creatinine level will be measured daily during 3 postoperative days.

    Measured: 3 days after surgery

  2. Postoperative cardiac troponin I level

    Cardiac troponin I level wil be measured in the time frame from 6 to 12 hours postoperatively.

    Measured: 12 hours after surgery

  3. Intraoperative blood pressure

    Intraoperative blood pressure (mean, systolic and diastolic) will be registered every 5 minutes intraoperatively using invasive blood pressure monitoring system.

    Measured: Operative day 1

  4. Rate of postoperative complications

    Postoperative complications (myocardial infarction, atrial fibrillation, stroke, delirium, need for renal replacement therapy, infection, reexploration for bleeding) will be defined according to standard European Society of Anaesthesiology/European Society of Intensive Care Medicine definitions where possible.

    Measured: 30 days after surgery

  5. Postoperative blood loss

    Drainage volume (ml/kg) will be measured in the next morning after surgery.

    Measured: Postoperative day 1

  6. Daily Sequential Organ Failure Assessment (SOFA) score

    Organ failure will be assessed by using Sequential Organ Failure Assessment (SOFA) score which will be recorded daily until patient discharge from the ICU. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). The score ranges from 0 to 24 points (the higher the score, the higher the mortality).

    Measured: 30 days after surgery

  7. Peak concentration of lactate during CPB and up to 24 hours after surgery

    Lactate values (mmol/l) will be measured every 6 hours during the first 24 postoperative hours.

    Measured: Postoperative day 1

  8. Oxygen delivery during CPB

    Oxygen delivery during CPB will be calculated according to the standard formula (pump flow x O2 arterial content).

    Measured: Operative day 1

  9. Cerebral oxygenation (near infrared spectroscopy)

    Number of cerebral desaturations will be recorded intraoperatively.

    Measured: Operative day1

  10. Ventilation > 24 hours

    Number of patients with duration of ventilation more than 24 h.

    Measured: 30 days after surgery

  11. Duration of ICU stay and hospitalization

    Number of postoperative days spent in the ICU and in the hospital will be counted.

    Measured: 30 days after surgery

  12. 30-day all-cause mortality

    Number of patients who will die within 30-day after surgery from any cause

    Measured: 30 days after surgery

  13. Need for blood transfusions

    Number of patients who will need transfusions of any blood products (RBC, fresh frozen plasma, platelets, cryoprecipitate).

    Measured: 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2018
  2. Study start21 Jan 2019
  3. Primary completion10 Mar 2020 (estimated)
  4. Study completion10 Apr 2020 (estimated)

Why it stopped: According to new guidelines, the use of vasopressors to force the MAP during CPB at values higher than 80 mmHg is not recommended.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03784690
Sponsor's protocol ID
19
Acronym
PRECISE
Status last verified
Nov 2019
First submitted
3 Oct 2018
Last updated
22 Nov 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29868971

  • 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.

    PubMed 23835589

  • 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.

    PubMed 15616043

  • 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.

    PubMed 19934864

  • 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.

    PubMed 29889106

  • 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.

    PubMed 7475182

Questions about this trial

What is this clinical trial studying?

A study testing Individualized intraoperative BP management and Standard intraoperative BP management in people with Cardiac Surgery, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compliance with the protocol (time frame: Operative day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03784690, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.

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