Preoperative VolumE Replacement therapy in DIabetic patients undergoing coronary artery bypass grafting surgery: results from an open parallel group randomized Controlled Trial (VeRDiCT).


Journal

Interactive cardiovascular and thoracic surgery
ISSN: 1569-9285
Titre abrégé: Interact Cardiovasc Thorac Surg
Pays: England
ID NLM: 101158399

Informations de publication

Date de publication:
01 01 2020
Historique:
received: 07 03 2019
revised: 20 08 2019
accepted: 23 08 2019
pubmed: 21 9 2019
medline: 10 6 2020
entrez: 21 9 2019
Statut: ppublish

Résumé

To investigate the effect of preoperative volume replacement therapy (VRT) on renal function, health outcome and time to fitness for discharge in diabetic patients undergoing coronary artery bypass grafting (CABG). In 2 parallel randomized controlled trials, diabetic patients were allocated to preoperative VRT (1 ml/kg/h of Hartmann's solution for 12 h) or usual care. Primary outcome was time to fitness for discharge. Secondary outcomes included acute kidney injury, postoperative complications, patient-reported quality of life (QoL), hospital resource use and markers of renal, cardiac and inflammatory injury. In total, 169 patients were randomized (84 VRT, 85 usual care; mean age 64 years; 88% male). Time to fitness for discharge was similar between groups [median 6 days; interquartile range 5.0-9.0 in both groups; hazard ratio 0.95, 95% confidence interval (CI) 0.65-1.38; P = 0.78]. Postoperative acute kidney injury was not statistically different (VRT: 27.7% vs usual care: 18.8%, odds ratio 1.72, 95% CI 0.82-3.59; P = 0.15). Estimated glomerular filtration rate (mean difference -0.92, 95% CI -4.18 to 2.25; P = 0.56), microalbumin/creatinine ratio [geometric mean ratio (GMR) 1.16, 95% CI 0.94-1.42; P = 0.16], N-acetyl-beta-d-glucosaminidase (GMR 1.08, 95% CI 0.83-1.40; P = 0.57), C-reactive protein (GMR 1.00, 95% CI 0.88-1.13; P = 0.94), troponin T (Trop-T; GMR 1.18, 95% CI 0.78-1.79; P = 0.39) and other secondary health outcomes were similar between groups. QoL improved in both groups at 3 months with no difference observed. The use of preoperative VRT is not superior to usual care in diabetic patients undergoing CABG. ISRCTN02159606.

Identifiants

pubmed: 31539025
pii: 5572153
doi: 10.1093/icvts/ivz226
doi:

Banques de données

ISRCTN
['ISRCTN02159606']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

54-63

Subventions

Organisme : Medical Research Council
ID : MR/J015350/1
Pays : United Kingdom
Organisme : Department of Health
ID : EME/15/180/55
Pays : United Kingdom
Organisme : British Heart Foundation
ID : CH/1992027/7163
Pays : United Kingdom
Organisme : British Heart Foundation
ID : PG/13/9/29990
Pays : United Kingdom
Organisme : British Heart Foundation
ID : PG/11/19/28827
Pays : United Kingdom

Informations de copyright

© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Auteurs

Kunal Sarkar (K)

Rabindranath Tagore International Institute of Cardiac Sciences (RTIICS), Kolkata, India.

Rosie A Harris (RA)

Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.

Sian Wells (S)

Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.

Tracy Harris (T)

Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.

Madeleine Clout (M)

Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.

Jodi Taylor (J)

Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.

Lucy Culliford (L)

Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.

Gianni D Angelini (GD)

Faculty of Health Sciences, Bristol Heart Institute, University of Bristol, Bristol, UK.

Katie Pike (K)

Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.

Kate Ashton (K)

Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.

Pradeep Narayan (P)

Rabindranath Tagore International Institute of Cardiac Sciences (RTIICS), Kolkata, India.

Barney Reeves (B)

Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.

James Hillier (J)

Faculty of Health Sciences, Bristol Heart Institute, University of Bristol, Bristol, UK.

Chris A Rogers (CA)

Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.

Raimondo Ascione (R)

Faculty of Health Sciences, Bristol Heart Institute, University of Bristol, Bristol, UK.

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