Ward based goal directed fluid therapy (GDFT) in acute pancreatitis (GAP) trial: A feasibility randomised controlled trial.
Acute pancreatitis
Cardiac output
Fluid therapy
Goal-directed fluid therapy
Journal
International journal of surgery (London, England)
ISSN: 1743-9159
Titre abrégé: Int J Surg
Pays: United States
ID NLM: 101228232
Informations de publication
Date de publication:
Aug 2022
Aug 2022
Historique:
received:
21
02
2022
revised:
13
06
2022
accepted:
14
06
2022
pubmed:
15
7
2022
medline:
31
8
2022
entrez:
14
7
2022
Statut:
ppublish
Résumé
Goal-directed fluid therapy (GDFT) reduces complications in patients undergoing major general surgery. There are no reports of cardiac output evaluation being used to optimise the fluid administration for patients with acute pancreatitis (AP) in a general surgery ward. 50 patients with AP were randomised to either ward-based GDFT (n = 25) with intravenous (IV) fluids administered based on stroke volume optimisation protocol or standard care (SC) (n = 25), but with blinded cardiac output evaluation, for 48-h following hospital admission. Primary outcome was feasibility. 50 of 116 eligible patients (43.1%) were recruited over 20 months demonstrating feasibility. 36 (72%) completed the 48-h of GDFT; 10 (20%) discharged within 48-h and 4 withdrawals (3 GDFT, 1 SC). Baseline characteristics were similar with only 3 participants having severe disease (6%, 1 GDFT, 2 SC). Similar volumes of IV fluids were administered in both groups (GDFT 5465 (1839) ml, SC 5211 (1745) ml). GDFT group had a lower heart rate, blood pressure and respiratory rate and improved oxygen saturations. GDFT was not associated with any harms. There was no evidence of difference in complications of AP (GDFT 24%, SC 32%) or in the duration of stay in intensive care (GDFT 0 (0), SC 0.7 (3) days). Length of hospital stay was 5 (2.9) days in GDFT and 6.3 (7.6) in SC groups. Ward-based GDFT is feasible and shows a signal of possible efficacy in AP in this early-stage study. A larger multi-site RCT is required to confirm clinical and cost effectiveness.
Sections du résumé
BACKGROUND
BACKGROUND
Goal-directed fluid therapy (GDFT) reduces complications in patients undergoing major general surgery. There are no reports of cardiac output evaluation being used to optimise the fluid administration for patients with acute pancreatitis (AP) in a general surgery ward.
METHOD
METHODS
50 patients with AP were randomised to either ward-based GDFT (n = 25) with intravenous (IV) fluids administered based on stroke volume optimisation protocol or standard care (SC) (n = 25), but with blinded cardiac output evaluation, for 48-h following hospital admission. Primary outcome was feasibility.
RESULTS
RESULTS
50 of 116 eligible patients (43.1%) were recruited over 20 months demonstrating feasibility. 36 (72%) completed the 48-h of GDFT; 10 (20%) discharged within 48-h and 4 withdrawals (3 GDFT, 1 SC). Baseline characteristics were similar with only 3 participants having severe disease (6%, 1 GDFT, 2 SC). Similar volumes of IV fluids were administered in both groups (GDFT 5465 (1839) ml, SC 5211 (1745) ml). GDFT group had a lower heart rate, blood pressure and respiratory rate and improved oxygen saturations. GDFT was not associated with any harms. There was no evidence of difference in complications of AP (GDFT 24%, SC 32%) or in the duration of stay in intensive care (GDFT 0 (0), SC 0.7 (3) days). Length of hospital stay was 5 (2.9) days in GDFT and 6.3 (7.6) in SC groups.
CONCLUSION
CONCLUSIONS
Ward-based GDFT is feasible and shows a signal of possible efficacy in AP in this early-stage study. A larger multi-site RCT is required to confirm clinical and cost effectiveness.
Identifiants
pubmed: 35835346
pii: S1743-9191(22)00514-3
doi: 10.1016/j.ijsu.2022.106737
pii:
doi:
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
106737Investigateurs
Jonathan Costello
(J)
Dimitris Tzelis
(D)
Christine Eastgate
(C)
Maria Jose Ciaponi
(MJ)
Margaret McNeil
(M)
Sara Mingo Garcia
(SM)
Glykeria Pakou
(G)
Otto Schwalowsky-Monks
(O)
Gretchelle Asis
(G)
Atokoleka Osakanu
(A)
Rebekkah Troller
(R)
Nikolaos Dimitrokallis
(N)
Stephanos Pericleous
(S)
Amjad Khalil
(A)
Aliza Abeles
(A)
Charles Rees
(C)
Khalid Abdulkareem
(K)
Mavroudis Voultsos
(M)
Informations de copyright
Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.