NCT00199771

Brief Summary

The purpose of this study is to determine whether infusion of hypertonic saline dextran attenuates the inflammatory response and the water overload, during and after major cardiac surgery in small children.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2003

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

June 1, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

July 1, 2011

Status Verified

January 1, 2008

Enrollment Period

1.5 years

First QC Date

September 13, 2005

Last Update Submit

June 30, 2011

Conditions

Heart Defects, CongenitalTransposition of Great VesselsHeart Septal Defects, VentricularEndocardial Cushion Defects

Keywords

Cardiac SurgeryInfantInfant, NewbornHypertonic SolutionsSaline Solution, HypertonicCapillary leakInflammation Mediators

Outcome Measures

Primary Outcomes (2)

  • IL-6 and IL-8 2 hours post CPB

  • Extra vascular lung water 2 and 24 hours post CPB

Secondary Outcomes (5)

  • Fluid balance

  • Weight gain

  • Cardiac output

  • Intrathorasic blood volume

  • Blood pressure during the first 24 hours post CPB

Interventions

7.5% NaCl in 6% dextran 70 solutionDRUG

Eligibility Criteria

AgeUp to 16 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients with congenital heart defect undergoing surgery using cardio pulmonary bypass (CPB).
  • Age below 17 weeks

You may not qualify if:

  • Preoperative: organ failure (other than heart), serum sodium \> 155 mmol/l, central venous pressure \> 12 mmHg
  • Perioperative: core temperature \< 25 ºC on CPB, re-heparinization, re-operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Defects, CongenitalTransposition of Great VesselsHeart Septal Defects, VentricularEndocardial Cushion Defects

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart Septal Defects

Study Officials

  • Gunnar Bentsen, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

June 1, 2003

Primary Completion

December 1, 2004

Study Completion

February 1, 2005

Last Updated

July 1, 2011

Record last verified: 2008-01