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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Hopital 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Calculated Blood Loss at 3rd Post Operative Day (POD)
Time Frame: 72H post surgery
72H post surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Queen Fabiola Children's University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 21, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 21, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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