Hypoplastic Left Heart Syndrome
Conditions
Brief summary
Babies born with hypoplastic left heart syndrome (HLHS) have three separate, complex heart surgeries before they turn three years of age. The first surgery typically happens in the first two weeks of life. After this operation, babies come back to the intensive care unit with their chests open. Babies who have heart surgery retain body water after surgery and this extra water slows recovery. Surgeons cannot close the chest until the baby gets rid of the extra water. As a result, babies have to stay in the intensive care unit and on a breathing machine for longer. Peritoneal dialysis, also known as PD, involves placing a small catheter into the belly cavity at the time of surgery. PD helps the kidney to get rid of extra body water. PD involves putting small amounts of special fluid into the belly through the catheter. This special fluid attracts water and is drained hourly. By allowing the belly cavity to drain, this helps both the heart and the lungs. This allows the chest to be closed and the breathing tube to be removed. The investigators are looking to see how quickly the babies, with and without PD, get rid of the extra water in turn shortening their stay in the intensive care unit and in the hospital. PD is not permanent, and only used for the first few days after the operation.
Interventions
DEVICEPeritoneal dialysis
Prophylactic peritoneal dialysis
Sponsors
Women and Children's Health Research Institute, Canada
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects randomized to peritoneal dialysis catheter (PDC) or no PDC and standard care.
Eligibility
Sex/Gender
ALL
Age
1 Days to 30 Days
Healthy volunteers
No
Inclusion criteria
* Infants with HLHS or its variants who have a Norwood procedure * Parental consent
Exclusion criteria
* Premature neonates less than 37 weeks gestation * Weight less than 2 kg * Urine output less than 0.5ml/kg/hr over 24 hours in the 48 hours prior to the Norwood * Pre-operative renal replacement therapy * Abdominal defects precluding placement of a PD catheter * Known chromosomal abnormality * Pre-operative cardiopulmonary resuscitation (CPR) * Pre-operative extra-corporeal life support (ECLS)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Post-operative Negative 24 Hour Fluid Balance | up to 72 hours | Time to first post-operative negative fluid balance which occurred in first 72 hrs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Sternal Closure | Up to 200 hours | — |
| Time to Lactate Less Than or Equal to 2mmol/L | From time of admission in PICU until assessment was reached, assessed up to 24 hours | Time to lactate less than or equal to 2mmol/L typically occurred in first 24 hrs |
| Time to First Extubation | Up to 15 days | — |
| Maximum Vasoactive Inotrope Score (VIS) on Post-operative Days 2-5 | Assessed at days 2, 3, 4 and 5 with the highest score from those 4 days reported | The maximum VIS assessed from days 2-5 will be chosen. A total VIS score is reported; there are no subscales. Minimum VIS is 0 (there are no units to VIS). Maximum VIS could be 100 but numbers are more typically 5-40. Higher VIS represent more inotropic support and potentially worse outcomes. |
| Hospital Length of Stay | Assessed up to 8 weeks | — |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prophylactic Peritoneal Dialysis Prophylactic peritoneal dialysis
Peritoneal dialysis: Prophylactic peritoneal dialysis | 10 |
| Standard Care Without PDC Standard care with diuretics | 12 |
| Total | 22 |
Baseline characteristics
| Characteristic | Prophylactic Peritoneal Dialysis | Standard Care Without PDC | Total |
|---|---|---|---|
| Age, Continuous | 9.2 Days STANDARD_DEVIATION 4 | 9.4 Days STANDARD_DEVIATION 5.5 | 9.3 Days STANDARD_DEVIATION 5 |
| Sex: Female, Male Female | 5 Participants | 2 Participants | 7 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 10 | 0 / 12 |
| other Total, other adverse events | 6 / 10 | 0 / 12 |
| serious Total, serious adverse events | 4 / 10 | 0 / 12 |
Outcome results
Primary
Time to First Post-operative Negative 24 Hour Fluid Balance
Time to first post-operative negative fluid balance which occurred in first 72 hrs
Time frame: up to 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prophylactic Peritoneal Dialysis | Time to First Post-operative Negative 24 Hour Fluid Balance | 2.7 Days | Standard Deviation 1.06 |
| Standard Care Without PDC | Time to First Post-operative Negative 24 Hour Fluid Balance | 2.67 Days | Standard Deviation 0.65 |
Secondary
Hospital Length of Stay
Time frame: Assessed up to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prophylactic Peritoneal Dialysis | Hospital Length of Stay | 20.4 days | Standard Deviation 10.8 |
| Standard Care Without PDC | Hospital Length of Stay | 27.7 days | Standard Deviation 21.4 |
Secondary
Maximum Vasoactive Inotrope Score (VIS) on Post-operative Days 2-5
The maximum VIS assessed from days 2-5 will be chosen. A total VIS score is reported; there are no subscales. Minimum VIS is 0 (there are no units to VIS). Maximum VIS could be 100 but numbers are more typically 5-40. Higher VIS represent more inotropic support and potentially worse outcomes.
Time frame: Assessed at days 2, 3, 4 and 5 with the highest score from those 4 days reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prophylactic Peritoneal Dialysis | Maximum Vasoactive Inotrope Score (VIS) on Post-operative Days 2-5 | 16.4 score on a scale | Standard Deviation 9.8 |
| Standard Care Without PDC | Maximum Vasoactive Inotrope Score (VIS) on Post-operative Days 2-5 | 15.0 score on a scale | Standard Deviation 5.3 |
Secondary
Time to First Extubation
Time frame: Up to 15 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prophylactic Peritoneal Dialysis | Time to First Extubation | 10.1 days | Standard Deviation 4.1 |
| Standard Care Without PDC | Time to First Extubation | 8.6 days | Standard Deviation 4.9 |
Secondary
Time to Lactate Less Than or Equal to 2mmol/L
Time to lactate less than or equal to 2mmol/L typically occurred in first 24 hrs
Time frame: From time of admission in PICU until assessment was reached, assessed up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prophylactic Peritoneal Dialysis | Time to Lactate Less Than or Equal to 2mmol/L | 15.5 Hours | Standard Deviation 10.1 |
| Standard Care Without PDC | Time to Lactate Less Than or Equal to 2mmol/L | 20.3 Hours | Standard Deviation 8.3 |
Secondary
Time to Sternal Closure
Time frame: Up to 200 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prophylactic Peritoneal Dialysis | Time to Sternal Closure | 5.33 days | Standard Deviation 2.87 |
| Standard Care Without PDC | Time to Sternal Closure | 4.17 days | Standard Deviation 1.12 |