Normothermic versus hypothermic cardiopulmonary bypass in low-risk paediatric heart surgery: A randomised controlled trial

Massimo Caputo*, Katie Pike, Sarah Baos, Karen Sheehan, Kathleen Selway, Lucy Ellis, Serban Stoica, Andrew Parry, Gemma Clayton, Lucy Culliford, Gianni Angelini, Ragini Pandey, Chris Rogers

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)

3 Citations (Scopus)
194 Downloads (Pure)

Abstract

OBJECTIVE: To compare normothermic (35°C-36°C) versus hypothermic (28°C) cardiopulmonary bypass (CPB) in paediatric patients undergoing open heart surgery to test the hypothesis that normothermic CPB perfusion maintains the functional integrity of major organ systems leading to faster recovery.

METHODS: Two single-centre, randomised controlled trials (known as Thermic-1 and Thermic-2, respectively) were carried out to compare the effectiveness and acceptability of normothermic versus hypothermic CPB in children with congenital heart disease undergoing open heart surgery. In both studies, the co-primary clinical outcomes were duration of inotropic support, intubation time and postoperative hospital stay.

RESULTS: In total, 200 participants were recruited; 59 to the Thermic-1 study and 141 to the Thermic-2 study. 98 patients received normothermic CPB and 102 patients received hypothermic CPB. There were no significant differences between the treatment groups for any of the co-primary outcomes: inotrope duration HR=1.01, 95% CI (0.72 to 1.41); intubation time HR=1.14, 95% CI (0.86 to 1.51); postoperative hospital stay HR=1.06, 95% CI (0.80 to 1.40). Differences favouring normothermia were found in urea nitrogen at 2 days geometric mean ratio (GMR)=0.86 95% CI (0.77 to 0.97); serum creatinine at 3 days GMR=0.89, 95% CI (0.81 to 0.98); urinary albumin at 48 hours GMR=0.32, 95% CI (0.14 to 0.74) and neutrophil gelatinase-associated lipocalin at 4 hours GMR=0.47, 95% CI (0.22 to 1.02), but not at other postoperative time points.

CONCLUSIONS: Normothermic CPB is as safe and effective as hypothermic CPB and can be routinely adopted as a perfusion strategy in low-risk infants and children undergoing open heart surgery.

TRIAL REGISTRATION NUMBER: ISRCTN93129502.

Original languageEnglish
Pages (from-to)455-464
Number of pages10
JournalHeart
Volume105
Issue number6
Early online date15 Oct 2018
DOIs
Publication statusPublished - 1 Mar 2019

Structured keywords

  • Centre for Surgical Research
  • BTC (Bristol Trials Centre)

Keywords

  • Blood Urea Nitrogen
  • Body Temperature/physiology
  • Cardiac Surgical Procedures/adverse effects
  • Cardiopulmonary Bypass/methods
  • Child
  • Creatinine/analysis
  • Female
  • Heart Defects, Congenital/surgery
  • Humans
  • Hypothermia, Induced/adverse effects
  • Infant
  • Lipocalin-2/analysis
  • Male
  • Postoperative Complications/diagnosis
  • Serum Albumin, Human/urine
  • Treatment Outcome

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    NIHR BRC Cardiovascular

    Angelini, G. D.

    1/04/1731/03/22

    Project: Research, Parent

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