Fluid Resuscitation in Acute Pancreatitis

March 10, 2016 updated by: Vanja Giljaca, University Hospital Rijeka

Randomized Trial of Standard vs. Enhanced Hydration in Patients With a Diagnosis of Acute Pancreatitis Within the First Hour of the Diagnosis

The aim of this study is to establish the influence of early administration of a bolus of intravascular fluid in patients with a diagnosis of acute pancreatitis on the course and outcome of disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized, controlled clinical trial of standard versus enhanced hydration in patients diagnosed with acute pancreatitis within the first hour of diagnosis.

Patients admitted in the Emergency Department with the clinical suspicion of acute pancreatitis will be processed through the history, physical examination and laboratory findings. The diagnosis of acute pancreatitis is established by the presence of 2 of the 3 following criteria: typical abdominal pain, serum amylase and / or lipase greater than three times the upper limit of normal, and characteristic findings from abdominal imaging. Patients will be informed about the study protocol and the possible risks and adverse events, after which they will be asked to accept participation in the study. Acceptance of participation will be confirmed by signed informed consent.

After acceptance patients will be randomized by computer-generated sequences of random numbers in the two groups Group one (1) will receive a bolus of fluid 20 ml / kg of Ringer's solution for infusion within one hour of the diagnosis and the group two (2) will receive a bolus of fluid 40 ml / kg of Ringer's solution for infusion within one hour of the diagnosis. All patients who have the diagnosis of acute pancreatitis, but did not agree to participate in research or have some other exclusion criteria will be treated according to the standards of good clinical practice and the recommendations of the current clinical guidelines for the treatment of acute pancreatitis. Exclusion criteria beside refusal to sign informed consent are: age less than 18 years, pregnancy, patients with physical signs of heart failure, previously known congestive heart failure (NYHA III - IV) and severe kidney disease more than one month before the diagnosis of acute pancreatitis (defined as severe reduction in eGFR less than 30 ml/min/1.73 m2). Patients who develop acute renal failure as a result of acute pancreatitis will be involved in research .

Given the importance of early hydration in patients with acute pancreatitis and the lack of clearly defined dose of administered fluid in the current literature, aim of this study was to determine the influence of the size of the dose bolus of intravascular fluid after the diagnosis of acute pancreatitis in the further course and outcome of disease.

The study will be conducted in the Emergency Department, Clinical Hospital Centre, Rijeka.

Study Type

Interventional

Enrollment (Anticipated)

903

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

All patients with diagnosis of acute pancreatitis.

Exclusion Criteria:

  1. Refusal to sign informed consent
  2. Age less than 18 years
  3. Pregnancy
  4. Patients with physical signs of heart failure,
  5. Previously known congestive heart failure ( NYHA III - IV )
  6. Severe kidney disease more than one month before the diagnosis of acute pancreatitis (defined as severe reduction in eGFR less than 30 ml/min/1.73 m2) . Patients who develop acute renal failure as a result of acute pancreatitis will be involved in research .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ringer lactate 20 mL/kg
This group of subjects will receive a bolus of 20 ml / kg of Ringer's solution for infusion within first hour of the diagnosis
Drug: Ringer lactate
Experimental: Ringer lactate 40 ml/kg
This group of subjects will receive a bolus of 40 ml / kg of Ringer's solution for infusion within first hour of the diagnosis
Drug: Ringer lactate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of mortality
Time Frame: Until hospital discharge or maximum of 1 month
Number of participants with fatal outcome during hospitalisation
Until hospital discharge or maximum of 1 month
Development of severe pancreatitis
Time Frame: Until hospital discharge or maximum of 1 month
Number of participants with severe pancreatitis during hospitalisation (according to revised Atlanta criteria)
Until hospital discharge or maximum of 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of peripancreatic collection
Time Frame: Until hospital discharge or maximum of 1 month
Number of participants with development of peripancreatic collection during hospitalisation
Until hospital discharge or maximum of 1 month
Development of pancreatic collection infection
Time Frame: Until hospital discharge or maximum of 1 month
Number of participants with development of pancreatic collection infection during hospitalisation
Until hospital discharge or maximum of 1 month
Development of systemic inflammatory response syndrome (SIRS)
Time Frame: Until hospital discharge or maximum of 1 month
Number of participants with development of systemic inflammatory response syndrome (SIRS)
Until hospital discharge or maximum of 1 month
Development of metabolic acidosis
Time Frame: Until hospital discharge or maximum of 1 month
Number of participants with development of metabolic acidosis
Until hospital discharge or maximum of 1 month
Development of acute respiratory distress syndrome (ARDS ) defined according to the current Berlin definition
Time Frame: Until hospital discharge or maximum of 1 month
Number of participants with development of acute respiratory distress syndrome (ARDS ) defined according to the current Berlin definition
Until hospital discharge or maximum of 1 month
Adverse events
Time Frame: Until hospital discharge or maximum of 1 month
All events during the treatment of patients who may or may not be associated with acute pancreatitis and / or replacement of fluids
Until hospital discharge or maximum of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Rijeka

Investigators

  • Study Chair: Vanja Giljača, M.D. PhD, University Hospital Rijeka

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

March 10, 2016

First Submitted That Met QC Criteria

March 10, 2016

First Posted (Estimate)

March 15, 2016

Study Record Updates

Last Update Posted (Estimate)

March 15, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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