PancreatitisPhase 2/3NCT02709044
Fluid Resuscitation in Acute Pancreatitis
A Phase 2/3 study testing Ringer lactate in people with Pancreatitis, run by University Hospital Rijeka at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis
- What is being tested?
- Ringer lactate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 903 participants
- Where
- 1 siteCroatia
- Study dates
- Feb 2016to Sep 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with diagnosis of acute pancreatitis.
Who cannot join
- Refusal to sign informed consent
- Age less than 18 years
- Pregnancy
- Patients with physical signs of heart failure,
- Previously known congestive heart failure ( NYHA III - IV )
- 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 .
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
UHRijeka
Rijeka, Rijeka, 51000
Vanja Giljača, M.D. PhD, +38551658380, vanja.giljaca@gmail.com
Petra Šverko, M.D., +38551658380, petrasverko@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatitis
- Being tested
- Ringer lactate
- Keywords
- Acute pancreatitis, Fluid resuscitation, Crystalloids
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer lactateDrug
| Study group | Role | What they receive |
|---|---|---|
| Ringer lactate 20 mL/kg | Experimental | This group of subjects will receive a bolus of 20 ml / kg of Ringer's solution for infusion within first hour of the diagnosis Receives: Drug: Ringer lactate |
| Ringer lactate 40 ml/kg | Experimental | This group of subjects will receive a bolus of 40 ml / kg of Ringer's solution for infusion within first hour of the diagnosis Receives: Drug: Ringer lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of mortality
Number of participants with fatal outcome during hospitalisation
Measured: Until hospital discharge or maximum of 1 month
Development of severe pancreatitis
Number of participants with severe pancreatitis during hospitalisation (according to revised Atlanta criteria)
Measured: Until hospital discharge or maximum of 1 month
Secondary outcomes (6)
Development of peripancreatic collection
Number of participants with development of peripancreatic collection during hospitalisation
Measured: Until hospital discharge or maximum of 1 month
Development of pancreatic collection infection
Number of participants with development of pancreatic collection infection during hospitalisation
Measured: Until hospital discharge or maximum of 1 month
Development of systemic inflammatory response syndrome (SIRS)
Number of participants with development of systemic inflammatory response syndrome (SIRS)
Measured: Until hospital discharge or maximum of 1 month
Development of metabolic acidosis
Number of participants with development of metabolic acidosis
Measured: Until hospital discharge or maximum of 1 month
Development of acute respiratory distress syndrome (ARDS ) defined according to the current Berlin definition
Number of participants with development of acute respiratory distress syndrome (ARDS ) defined according to the current Berlin definition
Measured: Until hospital discharge or maximum of 1 month
Adverse events
All events during the treatment of patients who may or may not be associated with acute pancreatitis and / or replacement of fluids
Measured: Until hospital discharge or maximum of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 903 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Rijeka
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanja Giljaca, University Hospital Rijeka
- Investigators
- Vanja Giljača, M.D. PhD, Study chair, University Hospital Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709044
- Sponsor's protocol ID
- AP01
- Status last verified
- Mar 2016
- First submitted
- 10 Mar 2016
- Last updated
- 15 Mar 2016
- Results posted
- No
Publications
Dugernier T, Starkel P, Laterre PF, Reynaert MS. Severe acute pancreatitis: pathophysiologic mechanisms underlying pancreatic necrosis and remote organ damage. Acta Gastroenterol Belg. 1996 Jul-Sep;59(3):178-85.
PubMed 9015927Cuthbertson CM, Christophi C. Disturbances of the microcirculation in acute pancreatitis. Br J Surg. 2006 May;93(5):518-30. doi: 10.1002/bjs.5316.
PubMed 16607683Zhao G, Zhang JG, Wu HS, Tao J, Qin Q, Deng SC, Liu Y, Liu L, Wang B, Tian K, Li X, Zhu S, Wang CY. Effects of different resuscitation fluid on severe acute pancreatitis. World J Gastroenterol. 2013 Apr 7;19(13):2044-52. doi: 10.3748/wjg.v19.i13.2044.
PubMed 23599623Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.
PubMed 23896955Bradley EL 3rd. A clinically based classification system for acute pancreatitis. Summary of the International Symposium on Acute Pancreatitis, Atlanta, Ga, September 11 through 13, 1992. Arch Surg. 1993 May;128(5):586-90. doi: 10.1001/archsurg.1993.01420170122019.
PubMed 8489394Vege SS, Chari ST. Organ failure as an indicator of severity of acute pancreatitis: time to revisit the Atlanta classification. Gastroenterology. 2005 Apr;128(4):1133-5. doi: 10.1053/j.gastro.2005.02.059. No abstract available.
PubMed 15825098Thoeni RF. The revised Atlanta classification of acute pancreatitis: its importance for the radiologist and its effect on treatment. Radiology. 2012 Mar;262(3):751-64. doi: 10.1148/radiol.11110947.
PubMed 22357880Vege SS, Gardner TB, Chari ST, Munukuti P, Pearson RK, Clain JE, Petersen BT, Baron TH, Farnell MB, Sarr MG. Low mortality and high morbidity in severe acute pancreatitis without organ failure: a case for revising the Atlanta classification to include "moderately severe acute pancreatitis". Am J Gastroenterol. 2009 Mar;104(3):710-5. doi: 10.1038/ajg.2008.77. Epub 2009 Feb 3.
PubMed 19262525Petrov MS, Windsor JA. Classification of the severity of acute pancreatitis: how many categories make sense? Am J Gastroenterol. 2010 Jan;105(1):74-6. doi: 10.1038/ajg.2009.597. Epub 2009 Oct 20.
PubMed 19844203Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
PubMed 23100216Ranson JH, Rifkind KM, Roses DF, Fink SD, Eng K, Spencer FC. Prognostic signs and the role of operative management in acute pancreatitis. Surg Gynecol Obstet. 1974 Jul;139(1):69-81. No abstract available.
PubMed 4834279Blamey SL, Imrie CW, O'Neill J, Gilmour WH, Carter DC. Prognostic factors in acute pancreatitis. Gut. 1984 Dec;25(12):1340-6. doi: 10.1136/gut.25.12.1340.
PubMed 6510766Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.
PubMed 3928249Singh VK, Wu BU, Bollen TL, Repas K, Maurer R, Johannes RS, Mortele KJ, Conwell DL, Banks PA. A prospective evaluation of the bedside index for severity in acute pancreatitis score in assessing mortality and intermediate markers of severity in acute pancreatitis. Am J Gastroenterol. 2009 Apr;104(4):966-71. doi: 10.1038/ajg.2009.28. Epub 2009 Mar 17.
PubMed 19293787Balthazar EJ. Staging of acute pancreatitis. Radiol Clin North Am. 2002 Dec;40(6):1199-209. doi: 10.1016/s0033-8389(02)00047-7.
PubMed 12479706
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Standard vs. Enhanced Hydration in Patients With a Diagnosis of Acute Pancreatitis Within the First Hour of the Diagnosis
- ClinicalTrials.gov ID
- NCT02709044
- Acronym / sponsor ID
- AP01
- Conditions
- Pancreatitis
- Keywords
- Acute pancreatitis, Fluid resuscitation, Crystalloids
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 903 participants (estimated)
- Lead sponsor
- University Hospital RijekaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ringer lactate 20 mL/kg | Experimental | Drug: Ringer lactateThis group of subjects will receive a bolus of 20 ml / kg of Ringer's solution for infusion within first hour of the diagnosis |
| Ringer lactate 40 ml/kg | Experimental | Drug: Ringer lactateThis group of subjects will receive a bolus of 40 ml / kg of Ringer's solution for infusion within first hour of the diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with diagnosis of acute pancreatitis.
Key exclusion criteria (6 listed)
- Refusal to sign informed consent
- Age less than 18 years
- Pregnancy
- Patients with physical signs of heart failure,
- Previously known congestive heart failure ( NYHA III - IV )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ringer lactate | Drug | Ringer lactate 20 mL/kg, Ringer lactate 40 ml/kg |
Primary outcome
Reduction of mortality
Time frame: Until hospital discharge or maximum of 1 month
Number of participants with fatal outcome during hospitalisation
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)
6 secondary outcomes
Development of peripancreatic collection
Time frame: Until hospital discharge or maximum of 1 month
Development of pancreatic collection infection
Time frame: 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
Development of metabolic acidosis
Time frame: 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
Adverse events
Time frame: Until hospital discharge or maximum of 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
- Background: PubMed 9015927Dugernier T, Starkel P, Laterre PF, Reynaert MS. Severe acute pancreatitis: pathophysiologic mechanisms underlying pancreatic necrosis and remote organ damage. Acta Gastroenterol Belg. 1996 Jul-Sep;59(3):178-85.
- Background: PubMed 16607683Cuthbertson CM, Christophi C. Disturbances of the microcirculation in acute pancreatitis. Br J Surg. 2006 May;93(5):518-30. doi: 10.1002/bjs.5316.
- Background: PubMed 23599623Zhao G, Zhang JG, Wu HS, Tao J, Qin Q, Deng SC, Liu Y, Liu L, Wang B, Tian K, Li X, Zhu S, Wang CY. Effects of different resuscitation fluid on severe acute pancreatitis. World J Gastroenterol. 2013 Apr 7;19(13):2044-52. doi: 10.3748/wjg.v19.i13.2044.
- Background: PubMed 23896955Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.
- Background: PubMed 8489394Bradley EL 3rd. A clinically based classification system for acute pancreatitis. Summary of the International Symposium on Acute Pancreatitis, Atlanta, Ga, September 11 through 13, 1992. Arch Surg. 1993 May;128(5):586-90. doi: 10.1001/archsurg.1993.01420170122019.
- Background: PubMed 15825098Vege SS, Chari ST. Organ failure as an indicator of severity of acute pancreatitis: time to revisit the Atlanta classification. Gastroenterology. 2005 Apr;128(4):1133-5. doi: 10.1053/j.gastro.2005.02.059. No abstract available.
- Background: PubMed 22357880Thoeni RF. The revised Atlanta classification of acute pancreatitis: its importance for the radiologist and its effect on treatment. Radiology. 2012 Mar;262(3):751-64. doi: 10.1148/radiol.11110947.
- Background: PubMed 19262525Vege SS, Gardner TB, Chari ST, Munukuti P, Pearson RK, Clain JE, Petersen BT, Baron TH, Farnell MB, Sarr MG. Low mortality and high morbidity in severe acute pancreatitis without organ failure: a case for revising the Atlanta classification to include "moderately severe acute pancreatitis". Am J Gastroenterol. 2009 Mar;104(3):710-5. doi: 10.1038/ajg.2008.77. Epub 2009 Feb 3.
- Background: PubMed 19844203Petrov MS, Windsor JA. Classification of the severity of acute pancreatitis: how many categories make sense? Am J Gastroenterol. 2010 Jan;105(1):74-6. doi: 10.1038/ajg.2009.597. Epub 2009 Oct 20.
- Background: PubMed 23100216Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
- Background: PubMed 4834279Ranson JH, Rifkind KM, Roses DF, Fink SD, Eng K, Spencer FC. Prognostic signs and the role of operative management in acute pancreatitis. Surg Gynecol Obstet. 1974 Jul;139(1):69-81. No abstract available.
- Background: PubMed 6510766Blamey SL, Imrie CW, O'Neill J, Gilmour WH, Carter DC. Prognostic factors in acute pancreatitis. Gut. 1984 Dec;25(12):1340-6. doi: 10.1136/gut.25.12.1340.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanja Giljača, M.D. PhD study chair
University Hospital Rijeka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ringer lactate in people with Pancreatitis, run by University Hospital Rijeka at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanja Giljača, M.D. PhD (+38551658885, vanja.giljača@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of mortality (time frame: Until hospital discharge or maximum of 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02709044, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2016; AzTrials last refreshed its copy on 6 Nov 2026.