Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid (COLCHIRCARD)

October 16, 2020 updated by: Queen Fabiola Children's University Hospital
This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during elective open-heart surgery in pediatric patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • Hôpital Universitaire des Enfants Reine Fabiola

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 3 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 28 days to 3 years old
  • Planned cardiac surgery with cardiopulmonary by-pass
  • signed informed consent

Exclusion Criteria:

  • Moribund patients (ASA 5)
  • Jehovah Witnesses
  • Pre-operative coagulation disorders
  • Pre-operative renal insufficiency
  • Pre-operative hepatic disorders
  • Intra-cranial hemorrhage
  • hypernatremia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Volulyte
Investigational drug: HES 130/0.4 (6%) in an isotonic electrolyte solution (brand name=Volulyte®)
Drug: Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution
Peri-operative fluid replacement therapy (max 40ml/kg/day)
Other Names:
  • Volulyte
Active Comparator: Voluven
Control drug: HES 130/0.4 (6%) in sodium chloride 0.9% (brand name=Voluven®)
Drug: Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride
Peri-operative fluid replacement therapy (max 40ml/kg/day)
Other Names:
  • Voluven

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Calculated Blood Loss at 3rd Post Operative Day (POD)
Time Frame: 72H post surgery
72H post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative Blood Loss
Time Frame: End of surgery, an average of 200 minutes
peri-operative blood losses in ml/kg at the end of surgery
End of surgery, an average of 200 minutes
Chest Tube Drainage
Time Frame: 72H post surgery
Total chest tube drainage during Pediatric Intensive Care Unit (PICU) stay
72H post surgery
Total Blood Loss
Time Frame: 72H post surgery
Total blood loss Intraoperative + chest tube drainage during Pediatric Intensive Care Unit (PICU) stay
72H post surgery
Exposure to Any Blood Products
Time Frame: 72H post surgery
Transfusion of any blood product (intraoperative + during Pediatric Intensive Care Unit stay)
72H post surgery
Exposure to Red Blood Cell
Time Frame: 72H post surgery
Transfusion of Red Blood Cell (intraoperative + during Pediatric Intensive Care Unit stay)
72H post surgery
Red Blood Cell Transfused
Time Frame: 72H post surgery
Red Blood Cell transfused in transfused patients in ml/kg (intraoperative + during Pediatric Intensive Care Unit stay)
72H post surgery
Exposure to Fresh Frozen Plasma
Time Frame: 72H post surgery
Transfusion of Fresh Frozen Plasma (intraoperative and during Pediatric Intensive Care Unit stay)
72H post surgery
Fresh Frozen Plasma Transfused
Time Frame: 72H post surgery
Fresh Frozen Plasma transfusion in ml/kg (intraoperative and during Pediatric Intensive Care Unit stay)
72H post surgery
Exposure to Platelets
Time Frame: 72H post surgery
Transfusion of platelets (intraoperative and during Pediatric Intensive Care Unit stay)
72H post surgery
Platelet Transfused
Time Frame: 72H post surgery
Platelet transfusion in ml/kg (intraoperative and during Pediatric Intensive Care Unit stay)
72H post surgery
Creatinine
Time Frame: At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery)
At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery)
C-Reactive Protein (CRP)
Time Frame: At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery)
At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery)
PTT
Time Frame: End of surgery, an average of 200 minutes
End of surgery, an average of 200 minutes
APTT
Time Frame: End of surgery, an average of 200 minutes
End of surgery, an average of 200 minutes
INR
Time Frame: End of surgery, an average of 200 minutes
End of surgery, an average of 200 minutes
Fibrinogen
Time Frame: End of surgery, an average of 200 minutes
End of surgery, an average of 200 minutes
Clotting Time in Seconds
Time Frame: End of surgery, an average of 200 minutes
Clotting time on EXTEM ROTEM®
End of surgery, an average of 200 minutes
Maximal Cloth Firmness
Time Frame: End of surgery, an average of 200 minutes
Maximal cloth firmness on EXTEM ROTEM®
End of surgery, an average of 200 minutes
Creatinine
Time Frame: Post-operative Day 1
Post-operative Day 1
CRP
Time Frame: Post-operative Day 1
Post-operative Day 1
PTT
Time Frame: Post-operative Day 1
Post-operative Day 1
APTT
Time Frame: Post-operative Day 1
Post-operative Day 1
INR
Time Frame: Post-operative Day 1
Post-operative Day 1
Fibrinogen
Time Frame: Post-operative Day 1
Post-operative Day 1
Creatinine
Time Frame: Post-operative Day 2
Post-operative Day 2
CRP
Time Frame: Post-operative Day 2
Post-operative Day 2
PTT
Time Frame: Post-operative Day 2
Post-operative Day 2
APTT
Time Frame: Post-operative Day 2
Post-operative Day 2
INR
Time Frame: Post-operative Day 2
Post-operative Day 2
Fibrinogen
Time Frame: Post-operative Day 2
Post-operative Day 2
Creatinine
Time Frame: Post-operative Day 3
Post-operative Day 3
CRP
Time Frame: Post-operative Day 3
Post-operative Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Fabiola Children's University Hospital

Investigators

  • Principal Investigator: Philippe Van der Linden, MDPhD, Huderf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2013

Primary Completion (Actual)

November 21, 2016

Study Completion (Actual)

November 21, 2016

Study Registration Dates

First Submitted

July 3, 2013

First Submitted That Met QC Criteria

October 22, 2015

First Posted (Estimate)

October 23, 2015

Study Record Updates

Last Update Posted (Actual)

November 9, 2020

Last Update Submitted That Met QC Criteria

October 16, 2020

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-006034-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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