NCT01685554

Brief Summary

The aim of our study was to evaluate the effect of different temperature regimens of cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during surgical correction of acquired heart diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2010

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

March 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 14, 2012

Completed
Last Updated

October 18, 2012

Status Verified

October 1, 2012

Enrollment Period

1.8 years

First QC Date

September 4, 2012

Last Update Submit

October 17, 2012

Conditions

Heart Valve Diseases

Keywords

perfusioncardiopulmonary bypasshypothermiacerebral oxygenation

Outcome Measures

Primary Outcomes (1)

  • Cerebral oxygen saturation

    measurement of cerebral oxygen saturation during cardiopulmonary bypass and 24 hrs postoperatively

    perioperatively

Secondary Outcomes (1)

  • time until "fit for ICU discharge" fulfillment

    5 days postoperatively

Study Arms (2)

normothermic CPB

ACTIVE COMPARATOR

cardiopulmonary bypass with maintenance of normal body temperature

Device: normothermic CPB

hypothermic CPB

ACTIVE COMPARATOR

cardiopulmonary bypass using mild hypothermia

Device: hypothermic CPB

Interventions

hypothermic CPBDEVICE

maintenance of mild hypothermia during cardiopulmonary bypass

hypothermic CPB
normothermic CPBDEVICE

maintenance of normal body temperature during cardiopulmonary bypass

normothermic CPB

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • requirement of surgical correction of two or more valves

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Anesthesiology, Northern SMU

Arkhangelsk, 163000, Russia

Location

Related Publications (1)

  • Lenkin AI, Zaharov VI, Lenkin PI, Smetkin AA, Bjertnaes LJ, Kirov MY. Normothermic cardiopulmonary bypass increases cerebral tissue oxygenation during combined valve surgery: a single-centre, randomized trial. Interact Cardiovasc Thorac Surg. 2013 May;16(5):595-601. doi: 10.1093/icvts/ivt016. Epub 2013 Feb 13.

    PMID: 23407696DERIVED

MeSH Terms

Conditions

Heart Valve DiseasesHypothermia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mikhail Y Kirov, MD, PhD

    Northern State Medical Univercity

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2012

First Posted

September 14, 2012

Study Start

March 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

October 18, 2012

Record last verified: 2012-10

Locations

RU(1)