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Ultrafiltration for Heart Surgery in Children (ULTRA Trial)
Phase 2 & 3
Recruiting
Research Sponsored by IWK Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Congenital heart patients (2.5 - 15kg) have consented for a planned cardiac surgery procedure requiring cardiopulmonary bypass.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days
Awards & highlights
ULTRA Trial Summary
This trial is studying two different types of ultrafiltration to see which is better at improving post-operative outcomes for infants and children who have had heart surgery.
Who is the study for?
This trial is for children with congenital heart disease weighing between 2.5 to 15kg, who are scheduled for cardiac surgery requiring cardiopulmonary bypass. Parents or guardians must consent to participate. It excludes those over 15kg (with some exceptions), without planned CPB use, isolated ASD repair, severe blood disorders, certain genetic syndromes with immune dysfunction, immunodeficiency syndromes, and severe liver or kidney disease.Check my eligibility
What is being tested?
The study tests two ultrafiltration protocols during heart surgery in kids: high-exchange (60ml/kg/hr) versus low-exchange (6ml/kg/hr). The goal is to see which better reduces inflammation from the heart-lung machine used in surgery and improves recovery outcomes.See study design
What are the potential side effects?
Ultrafiltration side effects may include shifts in fluid balance that could affect organ function temporarily. However, this procedure aims to reduce complications related to inflammation after using a heart-lung machine.
ULTRA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child, weighing between 2.5 and 15kg, is scheduled for heart surgery with cardiopulmonary bypass.
ULTRA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Continuous Positive Airway Pressure
Secondary outcome measures
C-Reactive Protein Concentrations
Composite Outcome of mechanical circulatory support, acute renal failure, prolonged intubation and death within 30 days.
Cytokine Concentration
+9 moreSide effects data
From 2012 Phase 3 trial • 188 Patients • NCT0060849118%
Cardiac Failure
13%
Cardiac Failure Acute
12%
Renal Failure
5%
Anaemia
3%
Renal Failure Acute
2%
Renal Failure Chronic
1%
Pulseless Electrical Activity
1%
Angina Pectoris
1%
Atrial Fibrillation
1%
Ventricular Fibrillation
1%
Ventricular Tachycardia
1%
Haematuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stepped Pharmacologic Care
Ultrafiltration
ULTRA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: High-Exchange UltrafiltrationExperimental Treatment1 Intervention
Subzero-Balance Simple Modified Ultrafiltration (60ml/kg/hour)
Group II: Low-Exchange UltrafiltraitonActive Control1 Intervention
Subzero-Balance Simple Modified Ultrafiltration (6ml/kg/hour)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrafiltration
2003
Completed Phase 3
~390
Find a Location
Who is running the clinical trial?
IWK Health CentreLead Sponsor
125 Previous Clinical Trials
100,377 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe liver or kidney disease.I have a severe blood disorder like sickle cell or hemophilia.I have a genetic condition like DiGeorge, Trisomy 18 or 13, or Noonan syndrome.I have a known immune system disorder or bone marrow disease.My child, weighing between 2.5 and 15kg, is scheduled for heart surgery with cardiopulmonary bypass.I am not scheduled for a procedure that requires a heart-lung machine.I weigh more than 15kg.I or my family do not wish to participate in the trial.I have had surgery to repair a hole in my heart.
Research Study Groups:
This trial has the following groups:- Group 1: High-Exchange Ultrafiltration
- Group 2: Low-Exchange Ultrafiltraiton
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available vacancies for this research project?
"Affirmative, the clinical trial is recruiting patients according to information on clinicaltrials.gov. The study was first posted on September 28th 2021 and has been edited recently on October 22nd 2021. 96 individuals are needed at a single site."
Answered by AI
How many individuals are part of this research project?
"The clinical trial is presently searching for participants. The clinical trial was first posted on 9/28/2021 and was most recently edited on 10/22/2021. The clinical trial is admitting 96 patients across 1 locations"
Answered by AI
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