NCT01338961

Brief Summary

Cardiopulmonary bypass (CPB) has been used successfully for cardiac surgery for over half a century. Hypothermia became a ubiquitous practice for adult patients undergoing CPB. To date, most studies have been conducted in coronary artery bypass graft (CABG) patients with conflicting results. Current evidence does not support one temperature management strategy for all patients. The purpose of this study is to compare the efficiency and safety of normothermic versus hypothermic CPB in valvular surgery patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

1.8 years

First QC Date

April 18, 2011

Last Update Submit

October 30, 2013

Conditions

Valvular Heart Disease

Keywords

Cardiopulmonary BypassHypothermiaNormothermiaTroponin IBleeding

Outcome Measures

Primary Outcomes (1)

  • Cardiac Troponin I release

    48 hours

Secondary Outcomes (11)

  • Need for Inotropic Support

    First 48 postoperative hours

  • Rate of Perioperative Myocardial Infarction

    First 48 postoperative hours

  • Rate of Type I and Type II neurological injury

    7 postoperative days

  • Rate of Dialysis-dependent acute renal failure

    7 postoperative days

  • Rate of infectious complications

    30 postoperative days

  • +6 more secondary outcomes

Study Arms (2)

Normothermic CPB

NO INTERVENTION

Standard management. Patients will be kept at normothermia throughout the procedure (\>36oC).

Hypothermic CPB

ACTIVE COMPARATOR

Patients will be cooled to 31-32oC (nasopharyngeal) after the beginning of CPB. Rewarming will begin 10-15 min before release of aortic cross-clamp. The gradient between heat-exchanger and nasopharynx during rewarming will be maintained at 3oC. The rewarming will be stopped at 36,5oC.

Procedure: Hypothermic CPB

Interventions

Hypothermic CPBPROCEDURE

Patients will be cooled to 31-32oC (nasopharyngeal) after the beginning of CPB. Rewarming will begin 10-15 min before release of aortic cross-clamp. The gradient between heat-exchanger and nasopharynx during rewarming will be maintained at 3oC. The rewarming will be stopped at 36,5oC

Hypothermic CPB

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Isolated heart valve surgery
  • Heart valve surgery plus CABG
  • Age 20-80

You may not qualify if:

  • urgent operation
  • Left ventricle ejection fraction \< 35%
  • Decompensated congestive heart failure
  • Chronic renal failure (glomerular filtration rate \< 60 ml/min)
  • Severe hepatic and pulmonary disease
  • Bleeding diathesis or history of coagulopathy
  • Planed deep hypothermic circulatory arrest
  • History of acute myocardial infarction in the last 3 month
  • Preoperative core temperature \>37oC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Research Institute of Circulation Patholody

Novosibirsk, 630055, Russia

Location

Related Publications (1)

  • Lomivorotov VV, Shmirev VA, Efremov SM, Ponomarev DN, Moroz GB, Shahin DG, Kornilov IA, Shilova AN, Lomivorotov VN, Karaskov AM. Hypothermic versus normothermic cardiopulmonary bypass in patients with valvular heart disease. J Cardiothorac Vasc Anesth. 2014 Apr;28(2):295-300. doi: 10.1053/j.jvca.2013.03.009. Epub 2013 Aug 17.

    PMID: 23962460RESULT

MeSH Terms

Conditions

Heart Valve DiseasesHypothermiaHemorrhage

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Vladimir V Lomivorotov, MD, PhD

    Research Institute of Pathology of Circulation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesist

Study Record Dates

First Submitted

April 18, 2011

First Posted

April 20, 2011

Study Start

April 1, 2011

Primary Completion

January 1, 2013

Study Completion

April 1, 2013

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

RU(1)