Ward-based Goal-Directed Fluid Therapy (GDFT) in Acute Pancreatitis (GAP) trial: study protocol for a feasibility randomised controlled trial

Froghi, Farid; Soggiu, Fiammetta; Ricciardi, Federico; Gurusamy, Kurinchi Selvan; Martin, Daniel; Singh, Jeshika; Siddique, Sulman; Eastgate, Christine; Ciaponi, Maria; McNeil, Margaret; Filipe, Helder; Schwalowsky-Monks, Otto; Asis, Gretchelle; Varcada, Massimo; Davidson, Brian R

doi:10.1136/bmjopen-2018-028783

Cited by 9 publications

(7 citation statements)

References 25 publications

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“…A detailed protocol of the GAP trial has been published [ 10 ]. In summary, it was designed as a two-centre, feasibility randomised controlled trial.…”

Section: Methodsmentioning

confidence: 99%

The integration of rapid qualitative research in clinical trials: reflections from the ward-based goal-directed fluid therapy (GDFT) in acute pancreatitis feasibility trial

Vindrola‐Padros

Froghi²,

Gopalan³

et al. 2023

Trials

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Background There has been an increase in the integration of qualitative studies in randomised controlled trials. The purpose of this article is to reflect on our experience of carrying out a rapid qualitative study during a feasibility trial of goal-directed fluid therapy (GDFT) in patients with acute pancreatitis, including our sharing of emerging findings and the use of these findings by the trial team. Methods The study was designed as a rapid feedback evaluation and combined interviews with staff and patients who took part in the trial. Findings The rapid qualitative study pointed to common problems in trial recruitment among multiple sites, where lack of engagement of clinical teams across sites might impact negatively on patient recruitment. The article describes how the use of rapid feedback loops can be used as the trial is ongoing to inform changes in implementation. It also covers the potential challenges of working rapidly and collaborative with the trial team. Conclusions Rapid feedback evaluations can be used to generate findings across all stages of trial design and delivery. Additional research is required to explore the implementation of this research design in other settings and trial designs.

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“…A detailed protocol of the GAP trial has been published [ 10 ]. In summary, it was designed as a two-centre, feasibility randomised controlled trial.…”

Section: Methodsmentioning

confidence: 99%

The integration of rapid qualitative research in clinical trials: reflections from the ward-based goal-directed fluid therapy (GDFT) in acute pancreatitis feasibility trial

Vindrola‐Padros

Froghi²,

Gopalan³

et al. 2023

Trials

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“…The clinical trial was conducted according to the previously published protocol (11). Adult patients (age 18 to 80 years) with a diagnosis of liver cirrhosis listed for LT at the Royal Free London NHS Foundation Hospital Trust, were invited to participate in the trial.…”

Section: Study Setting and Patientsmentioning

confidence: 99%

Effect of post-operative goal-directed fluid therapy (GDFT) on organ function after orthotopic liver transplantation: Secondary outcome analysis of the COLT randomised control trial

Froghi¹,

Gopalan²,

Anastasiou³

et al. 2022

International Journal of Surgery

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Background: Goal-directed fluid therapy (GDFT) has been shown to reduce the complications following a variety of major surgical procedures, possibly mediated by improved organ perfusion and function. We have shown that it is feasible to randomise patients to GDFT or standard fluid management following liver transplant in the cardiac-output optimisation following liver transplantation (COLT) trial. The current study compares end organ function in patients from the COLT trial who received GDFT in comparison to those receiving standard care (SC) following liver transplant.Methods: Adult patients with liver cirrhosis undergoing liver transplantation were randomised to GDFT or SC for the first 12 hours following surgery as detailed in a published trial protocol. GDFT protocol was based on stroke-volume (SV) optimisation using 250ml crystalloid boluses. Total fluid administration and time to extubation were recorded. Hourly SV and cardiac output (CO) readings were recorded from the non-invasive cardiac output monitoring (NICOM) device in both groups.Pulmonary function was assessed by arterial blood gas (ABG) and ventilatory parameters. Lung injury was assessed using PaO 2:FiO2 ratios and calculated pulmonary compliance. The KDIGO score was used for determining acute kidney injury. Renal and liver graft function were assessed during the post-operative period and at 3 months and 1-year.Results: 60 patients were randomised to GDFT (n=30) or SC (n=30). All patients completed the 12h intervention period. GDFT group received a significantly higher total volume of fluid during the 12h trial intervention period (GDFT 5317 (2335) vs. SC 3807 (1345) ml, p=0.003); in particular crystalloids (GDFT 3968 (2073) vs. SC 2510 (1027) ml, p=0.002). There was no evidence of significant difference between the groups in SV or CO during the assessment periods. Time to extubation, PaO2: FIO2 ratios, pulmonary compliance, ventilatory or blood gas measurements were similar in both groups.There was a significant rise in serum creatinine on from baseline (77μmol/L) compared to first (87μmol/L, p=0.039) and second (107μmol/L, p=0.001) post-operative days. There was no difference between GDFT and SC in the highest KDIGO scores for the first 7 days post-LT. At 1-year followup, there was no difference in need for renal replacement therapy or graft function. Conclusions:In this randomised trial of fluid therapy post liver transplant, GDFT was associated with an increased volume of crystalloids administered but did not alter early post-operative pulmonary or renal function when compared with standard care.

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“…A detailed protocol of the GAP trial has been published (Froghi et al, 2019). In summary, it was designed as a two-centre, feasibility randomised controlled trial.…”

Section: Trial Design and Deliverymentioning

confidence: 99%

The integration of rapid qualitative research in clinical trials: Reflections from the ward-based goal-directed fluid therapy (GDFT) in acute pancreatitis feasibility trial

Vindrola‐Padros

Froghi

Gopalan

et al. 2022

Preprint

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Purpose There has been an increase in the integration of qualitative studies in randomised controlled trials. However, many of these studies do not produce findings at a time when they can be used to inform decision-making processes on trial design and delivery, allowing for changes in real time. The purpose of this article is to address this gap by reflecting on our experience of carrying out a rapid qualitative study during a feasibility trial of goal-directed fluid therapy (GDFT) in patients with acute pancreatitis. Methods The study was designed as a rapid feedback evaluation and combined interviews with staff and patients who took part in the trial with a telephone audit of patients who declined participation. Findings : The rapid qualitative study pointed to common problems in trial recruitment among multiple sites, where lack of engagement of clinical teams across sites might impact negatively on patient recruitment. The study also pointed to issues encountered while implementing the trial that will be useful for informing the potential scale-up of the trial in the near future. Conclusions The rapid qualitative design can generate findings at a time when these can be used to inform changes in trial design and delivery. Additional research is required to explore the implementation of this research design in other settings and trial designs.

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Ward-based Goal-Directed Fluid Therapy (GDFT) in Acute Pancreatitis (GAP) trial: study protocol for a feasibility randomised controlled trial

Cited by 9 publications

References 25 publications

The integration of rapid qualitative research in clinical trials: reflections from the ward-based goal-directed fluid therapy (GDFT) in acute pancreatitis feasibility trial

The integration of rapid qualitative research in clinical trials: reflections from the ward-based goal-directed fluid therapy (GDFT) in acute pancreatitis feasibility trial

Effect of post-operative goal-directed fluid therapy (GDFT) on organ function after orthotopic liver transplantation: Secondary outcome analysis of the COLT randomised control trial

The integration of rapid qualitative research in clinical trials: Reflections from the ward-based goal-directed fluid therapy (GDFT) in acute pancreatitis feasibility trial

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