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Fluid Resuscitation in Acute Pancreatitis

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ClinicalTrials.gov Identifier: NCT02709044
Recruitment Status : Unknown
Verified March 2016 by Vanja Giljaca, University Hospital Rijeka.
Recruitment status was:  Recruiting
First Posted : March 15, 2016
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
Vanja Giljaca, University Hospital Rijeka

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatitis Drug: Ringer lactate Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 903 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Standard vs. Enhanced Hydration in Patients With a Diagnosis of Acute Pancreatitis Within the First Hour of the Diagnosis
Study Start Date : February 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

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



Primary Outcome Measures :
  1. Reduction of mortality [ Time Frame: Until hospital discharge or maximum of 1 month ]
    Number of participants with fatal outcome during hospitalisation

  2. 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)


Secondary Outcome Measures :
  1. Development of peripancreatic collection [ Time Frame: Until hospital discharge or maximum of 1 month ]
    Number of participants with development of peripancreatic collection during hospitalisation

  2. 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

  3. 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)

  4. Development of metabolic acidosis [ Time Frame: Until hospital discharge or maximum of 1 month ]
    Number of participants with development of metabolic acidosis

  5. 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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709044


Contacts
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Contact: Vanja Giljača, M.D. PhD +38551658885 vanja.giljača@gmail.com
Contact: Petra Šverko, M.D. +38598247655 petrasverko@gmail.com

Locations
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Croatia
UHRijeka Recruiting
Rijeka, Croatia, 51000
Contact: Vanja Giljača, M.D. PhD    +38551658380    vanja.giljaca@gmail.com   
Contact: Petra Šverko, M.D.    +38551658380    petrasverko@gmail.com   
Sponsors and Collaborators
University Hospital Rijeka
Investigators
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Study Chair: Vanja Giljača, M.D. PhD University Hospital Rijeka

Additional Information:
Publications:

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Responsible Party: Vanja Giljaca, M.D. PhD, University Hospital Rijeka
ClinicalTrials.gov Identifier: NCT02709044     History of Changes
Other Study ID Numbers: AP01
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: March 2016
Keywords provided by Vanja Giljaca, University Hospital Rijeka:
Acute pancreatitis
Fluid resuscitation
Crystalloids
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases