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

20. november 2019 oppdatert av: 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).

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Den russiske føderasjonen
      • Novosibirsk, Den russiske føderasjonen, 630055
        • Meshalkin Research Institute of Pathology of Circulation

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Individualized BP group
Individualized intraoperative BP management
Annen: 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 komparator: Standard treatment group
Standard intraoperative BP management
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Compliance with the protocol
Tidsramme: 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
Tidsramme: 12 month
Successful recruitment rate will be defined as recruitment of 2 patients per week.
12 month

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative creatinine concentration
Tidsramme: 3 days after surgery
Plasma creatinine level will be measured daily during 3 postoperative days.
3 days after surgery
Postoperative cardiac troponin I level
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: Operative day1
Number of cerebral desaturations will be recorded intraoperatively.
Operative day1
Ventilation > 24 hours
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Etterforskere

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

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

21. januar 2019

Primær fullføring (Forventet)

10. mars 2020

Studiet fullført (Forventet)

10. april 2020

Datoer for studieregistrering

Først innsendt

3. oktober 2018

Først innsendt som oppfylte QC-kriteriene

21. desember 2018

Først lagt ut (Faktiske)

24. desember 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. november 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. november 2019

Sist bekreftet

1. november 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 19

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Nei

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