NCT01398709

Brief Summary

The purpose of this study is to investigate the relationship between rewarming rate during cardiopulmonary bypass and clinical prognosis in infants undergoing cardiac surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 11, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

1.1 years

First QC Date

July 11, 2011

Last Update Submit

July 19, 2011

Conditions

Cardiac SurgeryCardiopulmonary BypassRewarming Rate

Keywords

Cardiopulmonary BypassPrognosisCardiac SurgeryRewarming Rate

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    one year

Secondary Outcomes (7)

  • Acute renal failure

    one month

  • Respiratory failure

    one month

  • ICU and hospital length of stay, and ICU readmissions

    one month

  • Stroke and reversible ischemic neurologic deficit

    one month

  • Measures of inflammation

    one month

  • +2 more secondary outcomes

Study Arms (2)

Slow rewarming strategy

ACTIVE COMPARATOR

Slow rewarming strategy (0.24 degrees C/min)

Other: Slow rewarming strategy

Fast rewarming strategy

ACTIVE COMPARATOR

Fast rewarming strategy (0.5 degrees C/min)

Other: Fast rewarming strategy

Interventions

Slow rewarming strategyOTHER

Rewarming rate:0.24 degrees C/min.

Slow rewarming strategy
Fast rewarming strategyOTHER

Rewarming rate:0.5 degrees C/min.

Fast rewarming strategy

Eligibility Criteria

AgeUp to 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants who had underwent cardiac surgery with cardiopulmonary bypass

You may not qualify if:

  • Preoperative liver or kidney disease or dysfunction
  • Preoperative coagulation disorder
  • Palliative operation or a second operation
  • Above 3 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shannxi, 710032, China

Location

Study Officials

  • Dinghua Yi, MD

    Xijing Hospital

    STUDY CHAIR

Central Study Contacts

Chunhu Gu, MD

CONTACT

guchunhu@fmmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2011

First Posted

July 20, 2011

Study Start

August 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations

CN(1)