Impact of intraoperative goal-directed fluid therapy on major morbidity and mortality after transthoracic oesophagectomy: a multicentre, randomised controlled trial

IntroductionAcute pancreatitis is an inflammatory disease of the pancreas with high risk of developing multiorgan failure and death. There are no effective pharmacological interventions used in current clinical practice. Maintaining fluid and electrolyte balance is the mainstay of supportive management. Goal-directed fluid therapy (GDFT) has been shown to decrease morbidity and mortality in surgical conditions with systemic inflammatory response. There is currently no randomised controlled trial (RCT) investigating the role of GDFT based on cardiac output parameters in patients with acute pancreatitis in the ward setting. A feasibility trial was designed to determine patient and clinician support for recruitment into an RCT of ward-based GDFT in acute pancreatitis, adherence to a GDFT protocol, safety, participant withdrawal, and to determine appropriate endpoints for a subsequent larger trial to evaluate efficacy.Methods and analysisThe GDFT in Acute Pancreatitis trial is a prospective two-centre feasibility RCT. Eligible adults admitted with new onset of acute pancreatitis will be enrolled and randomised into ward-based GDFT (n=25) or standard fluid therapy (n=25) within 6 hours from the diagnosis and continuing for the following 48 hours. Cardiac output parameters will be monitored with a non-invasive device (Cheetah NICOM; Cheetah Medical). The intervention group will consist of a protocolised GDFT approach consisting of stroke volume optimisation with crystalloid fluid boluses, while the control group will receive standard care fluid therapy as advised by the clinical team. The primary endpoint is feasibility. Secondary endpoints will include safety of the intervention, complications, mortality, admission to intensive care unit, cost and quality of life.Ethics and disseminationEthics approval was granted by the London Central Research Ethics Committee (17/LO/1235, project ID: 221872). The results of this trial will be presented to international conference with interest in general surgery and acute care and published in a peer-reviewed journal.Trial registration numberISRCTN36077283.

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Long-term effects of malaria prevention with insecticide-treated mosquito nets on morbidity and mortality in African children: randomised controlled trial

Tropical Medicine & International Health ◽

10.1111/j.1365-3156.2012.02990.x ◽

2012 ◽

Vol 17 (6) ◽

pp. 733-741 ◽

Cited By ~ 6

Author(s):

Valérie R. Louis ◽

Joëlle Bals ◽

Justin Tiendrebéogo ◽

Mamadou Bountogo ◽

Heribert Ramroth ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Malaria Prevention ◽

Morbidity And Mortality ◽

Long Term Effects ◽

African Children ◽

Mosquito Nets ◽

Randomised Controlled

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Isotonic versus hypotonic saline as maintenance intravenous fluid therapy in children under 5 years of age admitted to general paediatric wards: a randomised controlled trial

Paediatrics and International Child Health ◽

10.1080/20469047.2019.1619059 ◽

2019 ◽

Vol 40 (1) ◽

pp. 44-49 ◽

Cited By ~ 1

Author(s):

Manish Kumar ◽

Kaustav Mitra ◽

Rahul Jain

Keyword(s):

Randomised Controlled Trial ◽

Fluid Therapy ◽

Controlled Trial ◽

Intravenous Fluid ◽

Intravenous Fluid Therapy ◽

Hypotonic Saline ◽

Randomised Controlled ◽

Children Under 5

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The Plasma-Lyte 148 versus Saline (PLUS) statistical analysis plan: a multicentre, randomised controlled trial of the effect of intensive care fluid therapy on mortality

Critical Care and Resuscitation ◽

10.51893/2021.1.oa2 ◽

2021 ◽

Vol 23 (1) ◽

pp. 24-31

Author(s):

Laurent Billot ◽

◽

Rinaldo Bellomo ◽

Martin Gallagher ◽

David Gattas ◽

...

Keyword(s):

Statistical Analysis ◽

Randomised Controlled Trial ◽

Fluid Resuscitation ◽

Fluid Therapy ◽

Controlled Trial ◽

Internal Validity ◽

Statistical Analysis Plan ◽

Sensitivity Analyses ◽

Process Measures ◽

Randomised Controlled

BACKGROUND AND OBJECTIVE:The Plasma-Lyte 148 versus Saline (PLUS) study is a prospective, multicentre, parallel-group, concealed, blinded, randomised controlled trial comparing the effect of Plasma-Lyte 148 versus 0.9% sodium chloride (saline) for fluid resuscitation and other fluid therapy on 90-day mortality among critically ill adults requiring fluid resuscitation. The original target for recruitment was 8800 participants, which was reduced to 5000 participants following the onset of the coronavirus disease 2019 (COVID-19) pandemic in 2020. This article describes the statistical analysis plan for the PLUS study. METHODS: The statistical analysis plan was developed by the study statistician, chief investigator, and project manager, and was approved by the Management Committee before unblinding. The plan describes in detail the analysis of baseline characteristics, process measures, and outcomes, including covariate adjustments, subgroup analyses, missing data handling, and sensitivity analyses. RESULTS AND CONCLUSIONS: A statistical analysis plan for the PLUS study was developed. This pre-specified plan accords with high quality standards of internal validity and should minimise future analysis bias.

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