TY - JOUR
T1 - Ward based goal directed fluid therapy (GDFT) in acute pancreatitis (GAP) trial
T2 - A feasibility randomised controlled trial
AU - GAP Collaborators
AU - Froghi, Farid
AU - Soggiu, Fiammetta
AU - Ricciardi, Federico
AU - Vindrola-Padros, Cecilia
AU - Floros, Lefteris
AU - Martin, Daniel
AU - Filipe, Helder
AU - Varcada, Massimo
AU - Gurusamy, Kurinchi
AU - Bhattacharya, Satya
AU - Fanshawe, Angela
AU - Delcea, Bogdan
AU - Mathur, Pawan
AU - Davidson, Brian
AU - Costello, Jonathan
AU - Tzelis, Dimitris
AU - Eastgate, Christine
AU - Ciaponi, Maria Jose
AU - McNeil, Margaret
AU - Garcia, Sara Mingo
AU - Pakou, Glykeria
AU - Schwalowsky, Otto
AU - Asis, Gretchelle
AU - Osakanu, Atokoleka
AU - Troller, Rebekkah
AU - Dimitrokallis, Nikolaos
AU - Pericleous, Stephanos
AU - Khalil, Amjad
AU - Abeles, Aliza
AU - Rees, Charles
AU - Abdulkareem, Khalid
AU - Voultsos, Mavroudis
N1 - Publisher Copyright:
© 2022 The Author(s)
PY - 2022/8
Y1 - 2022/8
N2 - 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: 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: 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: 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.
AB - 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: 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: 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: 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.
KW - Acute pancreatitis
KW - Cardiac output
KW - Fluid therapy
KW - Goal-directed fluid therapy
UR - http://www.scopus.com/inward/record.url?scp=85135923813&partnerID=8YFLogxK
U2 - 10.1016/j.ijsu.2022.106737
DO - 10.1016/j.ijsu.2022.106737
M3 - Article
C2 - 35835346
AN - SCOPUS:85135923813
SN - 1743-9191
VL - 104
JO - International Journal of Surgery
JF - International Journal of Surgery
M1 - 106737
ER -