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Individualized Blood Pressure Management in Patients Undergoing Cardiac Surgery (PRECISE)

20 november 2019 bijgewerkt door: Meshalkin Research Institute of Pathology of Circulation

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).

Studie Overzicht

Toestand

Ingetrokken

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Russische Federatie
      • Novosibirsk, Russische Federatie, 630055
        • Meshalkin Research Institute of Pathology of Circulation

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Individualized BP group
Individualized intraoperative BP management
Ander: Individualized intraoperative BP management

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.
Placebo-vergelijker: Standard treatment group
Standard intraoperative BP management
Ander: Standard intraoperative BP management
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Compliance with the protocol
Tijdsspanne: Operative day 1
Successful compliance with protocol is defined as ≥ 90% of prescribed intervention being administered across all patients.
Operative day 1
Successful recruitment rate
Tijdsspanne: 12 month
Successful recruitment rate will be defined as recruitment of 2 patients per week.
12 month

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Postoperative creatinine concentration
Tijdsspanne: 3 days after surgery
Plasma creatinine level will be measured daily during 3 postoperative days.
3 days after surgery
Postoperative cardiac troponin I level
Tijdsspanne: 12 hours after surgery
Cardiac troponin I level wil be measured in the time frame from 6 to 12 hours postoperatively.
12 hours after surgery
Intraoperative blood pressure
Tijdsspanne: Operative day 1
Intraoperative blood pressure (mean, systolic and diastolic) will be registered every 5 minutes intraoperatively using invasive blood pressure monitoring system.
Operative day 1
Rate of postoperative complications
Tijdsspanne: 30 days after surgery
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.
30 days after surgery
Postoperative blood loss
Tijdsspanne: Postoperative day 1
Drainage volume (ml/kg) will be measured in the next morning after surgery.
Postoperative day 1
Daily Sequential Organ Failure Assessment (SOFA) score
Tijdsspanne: 30 days after surgery
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).
30 days after surgery
Peak concentration of lactate during CPB and up to 24 hours after surgery
Tijdsspanne: Postoperative day 1
Lactate values (mmol/l) will be measured every 6 hours during the first 24 postoperative hours.
Postoperative day 1
Oxygen delivery during CPB
Tijdsspanne: Operative day 1
Oxygen delivery during CPB will be calculated according to the standard formula (pump flow x O2 arterial content).
Operative day 1
Cerebral oxygenation (near infrared spectroscopy)
Tijdsspanne: Operative day1
Number of cerebral desaturations will be recorded intraoperatively.
Operative day1
Ventilation > 24 hours
Tijdsspanne: 30 days after surgery
Number of patients with duration of ventilation more than 24 h.
30 days after surgery
Duration of ICU stay and hospitalization
Tijdsspanne: 30 days after surgery
Number of postoperative days spent in the ICU and in the hospital will be counted.
30 days after surgery
30-day all-cause mortality
Tijdsspanne: 30 days after surgery
Number of patients who will die within 30-day after surgery from any cause
30 days after surgery
Need for blood transfusions
Tijdsspanne: 30 days after surgery
Number of patients who will need transfusions of any blood products (RBC, fresh frozen plasma, platelets, cryoprecipitate).
30 days after surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Onderzoekers

  • Hoofdonderzoeker: Vladimir Lomivorotov, MD, PhD, Meshalkin Research Institute of Pathology of Circulation

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

21 januari 2019

Primaire voltooiing (Verwacht)

10 maart 2020

Studie voltooiing (Verwacht)

10 april 2020

Studieregistratiedata

Eerst ingediend

3 oktober 2018

Eerst ingediend dat voldeed aan de QC-criteria

21 december 2018

Eerst geplaatst (Werkelijk)

24 december 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 november 2019

Laatste update ingediend die voldeed aan QC-criteria

20 november 2019

Laatst geverifieerd

1 november 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 19

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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