Cardiac DiseasesNCT00464126
The Use of Colloid Versus Crystalloid in Post-operative Pediatric Cardiac Patients for Fluid Resuscitation
A study testing 5% albumin and crystalloid in people with Cardiac Diseases, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of the study is to help determine if either crystalloid solution or colloid solution is more advantageous as a resuscitative fluid in post-operative pediatric cardiac patients. Read more about this study
- Who is it for?
- Ages 1 day to 36 months
- Conditions the study is for
- Cardiac Diseases
- What is being tested?
- 5% albumin and crystalloid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Congenital heart defect with two ventricle anatomy and physiology
- Ages: 0 - 36 months of age
Who cannot join
- History of bleeding disorder
- History of renal disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
The Monroe Carell, Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232-9075
About this study
The purpose of the study is to help determine if either crystalloid solution or colloid solution is more advantageous as a resuscitative fluid in post-operative pediatric cardiac patients.
Read the detailed description
The study is designed to help detect if there is an advantage in giving one type of resuscitative fluid versus another in the setting of post-operative pediatric cardiac patients. The two types of fluid being compared are crystalloid solution (normal saline) and colloid solution (5% albumin). The primary outcome measurement will be how much volume of each type of fluid will be required in order to maintain hemodynamic stability as determined by mean arterial blood pressure within predetermined parameters. Other secondary outcomes will include determinations of lactate clearance, inotropic support requirements, urine output, peripheral and pulmonary edema that occurs post-operatively, and the over all costs for each fluid based on number of required boluses and number of hours on mechanical ventilation.
- Conditions
- Cardiac Diseases
- Being tested
- 5% albumin, crystalloid
- Keywords
- crystalloid, colloid, pediatric, cardiac, resuscitation, Postoperative
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% albuminOther
Also called colloid, albumin
5% albumin in 10cc/kg aliquots for postoperative volume resuscitation
crystalloidOther
Also called saline
saline in 10cc/kg aliquots for postoperative volume resuscitation
| Study group | Role | What they receive |
|---|---|---|
| Colloid | Active comparator | 5% albumin for volume resuscitation Receives: Other: 5% albumin |
| Crystalloid | Placebo comparator | Saline for volume resuscitation Receives: Other: crystalloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
maintenance of hemodynamic stability according to an age specific, predetermined, minimal mean arterial blood pressure
Measured: Throughout the post operative period
Secondary outcomes (5)
lactate clearance
Measured: Throughout the post operative period
inotropic requirements
Measured: throughout the post operative period
establishment of adequate urine output
Measured: Throughout the post operative period
post-operative occurrence of edema (peripheral and pulmonary)
Measured: Througout the post operative period
monitoring of cost difference as determined by total number of boluses, number of ventilator hours, and length of ICU stay
Measured: Throughout the ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startAug 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseasesStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary B Taylor, M.D., MSCI, Principal investigator, Vanderbilt University Medical Center Department of Pediatrics Division of Critical Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464126
- Sponsor's protocol ID
- IRB#: 020775
- Status last verified
- Mar 2017
- First submitted
- 18 Aug 2006
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Colloid Versus Crystalloid in Post-operative Pediatric Cardiac Patients for Fluid Resuscitation
- ClinicalTrials.gov ID
- NCT00464126
- Acronym / sponsor ID
- IRB#: 020775
- Conditions
- Cardiac Diseases
- Keywords
- crystalloid, colloid, pediatric, cardiac, resuscitation, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 20 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to help determine if either crystalloid solution or colloid solution is more advantageous as a resuscitative fluid in post-operative pediatric cardiac patients.
Detailed description
The study is designed to help detect if there is an advantage in giving one type of resuscitative fluid versus another in the setting of post-operative pediatric cardiac patients. The two types of fluid being compared are crystalloid solution (normal saline) and colloid solution (5% albumin). The primary outcome measurement will be how much volume of each type of fluid will be required in order to maintain hemodynamic stability as determined by mean arterial blood pressure within predetermined parameters. Other secondary outcomes will include determinations of lactate clearance, inotropic support requirements, urine output, peripheral and pulmonary edema that occurs post-operatively, and the over all costs for each fluid based on number of required boluses and number of hours on mechanical ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colloid | Active comparator | Other: 5% albumin5% albumin for volume resuscitation |
| Crystalloid | Placebo comparator | Other: crystalloidSaline for volume resuscitation |
Who may qualify
- Ages
- 1 day to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Congenital heart defect with two ventricle anatomy and physiology
- Ages: 0 - 36 months of age
Key exclusion criteria (2 listed)
- History of bleeding disorder
- History of renal disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% albuminAlso: colloid, albumin5% albumin in 10cc/kg aliquots for postoperative volume resuscitation | Other | Colloid |
| crystalloidAlso: salinesaline in 10cc/kg aliquots for postoperative volume resuscitation | Other | Crystalloid |
Primary outcome
maintenance of hemodynamic stability according to an age specific, predetermined, minimal mean arterial blood pressure
Time frame: Throughout the post operative period
5 secondary outcomes
lactate clearance
Time frame: Throughout the post operative period
inotropic requirements
Time frame: throughout the post operative period
establishment of adequate urine output
Time frame: Throughout the post operative period
post-operative occurrence of edema (peripheral and pulmonary)
Time frame: Througout the post operative period
monitoring of cost difference as determined by total number of boluses, number of ventilator hours, and length of ICU stay
Time frame: Throughout the ICU stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary B Taylor, M.D., MSCI principal investigator
Vanderbilt University Medical Center Department of Pediatrics Division of Critical Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5% albumin and crystalloid in people with Cardiac Diseases, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maintenance of hemodynamic stability according to an age specific, predetermined, minimal mean arterial blood pressure (time frame: Throughout the post operative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.