Prophylactic peritoneal dialysis catheter does not decrease time to achieve a negative fluid balance after the Norwood procedure: a randomized controlled trial
Lindsay M Ryerson, Andrew S Mackie, Joseph Atallah, Ari R Joffe, Ivan M Rebeyka, David B Ross, Ian Adatia, Lindsay M Ryerson, Andrew S Mackie, Joseph Atallah, Ari R Joffe, Ivan M Rebeyka, David B Ross, Ian Adatia
Abstract
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.
Trial registration: ClinicalTrials.gov NCT01215240.
Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.
Source: PubMed
Prochains essais cliniques
-
Magnus MedicalCongressionally Directed Medical Research ProgramsRecrutement
-
Nicholas ButowskiSiren BiotechnologyPas encore de recrutementGliome | Tumeur cérébrale | Gliomes récurrents de haut gradeÉtats-Unis
-
State University of New York at BuffaloPas encore de recrutementParticipation des patientsÉtats-Unis
-
Poitiers University HospitalPas encore de recrutement
-
Assistance Publique - Hôpitaux de ParisPas encore de recrutementDrépanocytose | Crise vaso-occlusive
-
University of California, IrvineRecrutementCancer du cerveau | Cancer du SNC | Cancer du système nerveux | Cancer du cerveau métastatiqueÉtats-Unis
-
Qualia Life SciencesRecrutement
-
Guangdong Raynovent Biotech Co., LtdPas encore de recrutement
-
The Hong Kong Polytechnic UniversityWu Jieh Yee Charitable FoundationRecrutementAdultes | Assistance numérique basse vision | Troubles de la visionHong Kong
-
Shanghai General Hospital, Shanghai Jiao Tong University...Pas encore de recrutementAdénocarcinome canalaire pancréatique (PDAC)
-
Sun Yat-sen UniversityPas encore de recrutementSevrage tabagique | Agent IA | Early-Stage Cancer
-
Affiliated Hospital of Nantong UniversityPas encore de recrutement