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Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Prophylactic peritoneal dialysis catheter does not decrease time to achieve a negative fluid balance after the Norwood procedure: a randomized controlled trial.
Journal of Thoracic and Cardiovascular Surgery 2015 January
OBJECTIVE: Infants and children who undergo cardiopulmonary bypass and cardiac surgery are at risk of postoperative fluid overload. Peritoneal dialysis catheter (PDC) and peritoneal dialysis are reported to be effective means of postoperative fluid management. We sought to test the hypothesis that PDC insertion in the operating room at the time of Norwood palliation would decrease the time to achieve a negative fluid balance in a group of neonates with hypoplastic left heart syndrome.
METHODS: A single center randomized controlled trial was performed. We randomized neonates with hypoplastic left heart syndrome to prophylactic PDC, with or without dialysis, or standard care (ie, no PDC).
RESULTS: Twenty-two neonates were included; 10 were randomized to PDC and 12 were randomized to standard care. The mean time to first postoperative negative fluid balance was 2.70 ± 1.06 days for the prophylactic PDC group and 2.67 ± 0.65 days for the standard care group (P = .93). There was no difference between the 2 groups in time to lactate ≤ 2 mmol/L, maximum vasoactive-inotrope score on postoperative days 2 to 5, time to sternal closure, time to first extubation, modified clinical outcome score, or hospital length of stay. Twenty-one patients (95%) survived to hospital discharge. Four patients randomized to prophylactic PDC had 1 or more serious adverse events compared with no patients in the standard care group (P = .03).
CONCLUSIONS: Prophylactic PDC, with or without dialysis, did not decrease the time to achieve a negative fluid balance after the Norwood procedure, did not alter physiological variables postoperatively, and was associated with more severe adverse events.
METHODS: A single center randomized controlled trial was performed. We randomized neonates with hypoplastic left heart syndrome to prophylactic PDC, with or without dialysis, or standard care (ie, no PDC).
RESULTS: Twenty-two neonates were included; 10 were randomized to PDC and 12 were randomized to standard care. The mean time to first postoperative negative fluid balance was 2.70 ± 1.06 days for the prophylactic PDC group and 2.67 ± 0.65 days for the standard care group (P = .93). There was no difference between the 2 groups in time to lactate ≤ 2 mmol/L, maximum vasoactive-inotrope score on postoperative days 2 to 5, time to sternal closure, time to first extubation, modified clinical outcome score, or hospital length of stay. Twenty-one patients (95%) survived to hospital discharge. Four patients randomized to prophylactic PDC had 1 or more serious adverse events compared with no patients in the standard care group (P = .03).
CONCLUSIONS: Prophylactic PDC, with or without dialysis, did not decrease the time to achieve a negative fluid balance after the Norwood procedure, did not alter physiological variables postoperatively, and was associated with more severe adverse events.
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