None listed
Conditions
Brief summary
Background: Children undergoing heart surgery require cardiopulmonary bypass. This is a technique which takes over the work of the heart and lungs so the surgeon can perform the operation. The use of cardiopulmonary bypass often causes a reaction in the child called systemic inflammatory response (or SIRS for short). Children who develop SIRS are much more likely to have complications in intensive care (cardiac arrest, need for time on a breathing machine, prolonged intensive care stay and even death). Doctors and nurses at the Royal Children’s Hospital are very interested in studying and preventing SIRS. Peritoneal dialysis is a therapy often used in children after heart surgery; it is also used in children and adults to provide artificial kidney function. It involves placing fluid in the abdomen and using the lining to remove fluids and substances. We have observed that the early use of this therapy soon after heart operation is associated with improved outcomes. Peritoneal dialysis might reduce the risk of SIRS. Proposed study: We plan to study the role of early peritoneal dialysis in preventing the complications of SIRS in babies less than six months of age. The study will be conducted in the Cardiac Intensive Care Unit at the Royal Children’s Hospital, Melbourne. We have calculated we will need 312 infants in the study and hope to find out if early peritoneal dialysis helps reduce complications of SIRS following cardiac surgery. Babies will either get early peritoneal dialysis or normal care. Early peritoneal dialysis will start within an hour of arriving in the intensive care unit after heart surgery and will continue for 24 hours. Normal care babies will only get peritoneal dialysis if they need it for artificial kidney function. Potential implications for child health: This study will help to answer the question: “Does early peritoneal dialysis really help babies after heart surgery ?”.It will help make decisions about treatments after heart surgery. This is important for doctors and nurses working in intensive care units around the world. Peritoneal dialysis is a low cost treatment and if early commencement of this therapy after surgery is shown to positively influence outcomes it will have important implications for children born with congenital heart disease.
Interventions
Infants in the treatment group will be commenced on peritoneal dialysis as soon as possible (no later than 60 minutes) after admission to ICU following cardiac surgery. The treatment will be provided for a total of 24 hours (24 cycles in total)
Sponsors
The Royal Children's Hospital Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 180 Days
Healthy volunteers
No
Inclusion criteria
Infants less than or equal to 180 days of age who have had cardiac surgery (in RACHS-1 categories 3 to 6) with cardiopulmonary bypass will be eligible, providing they have a peritoneal dialysis catheter in place at the time of admission to ICU and are expected to be ventilated for at least 24 hours
Exclusion criteria
The exclusions will be: 1) if withdrawal of treatment is being considered 2) infants who have already participated in the same trial during a previous cardiac surgery 3) children already on extracorporeal membrane oxygenation (ECMO) at the time of admission from the operating theatre and 4) infants whose parents refuse consent.
Outcome results
None listed