NCT02709044

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
903

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

2.1 years

First QC Date

March 10, 2016

Last Update Submit

March 10, 2016

Conditions

Pancreatitis

Keywords

Acute pancreatitisFluid resuscitationCrystalloids

Outcome Measures

Primary Outcomes (2)

  • Reduction of mortality

    Number of participants with fatal outcome during hospitalisation

    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)

    Until hospital discharge or maximum of 1 month

Secondary Outcomes (6)

  • Development of peripancreatic collection

    Until hospital discharge or maximum of 1 month

  • Development of pancreatic collection infection

    Until hospital discharge or maximum of 1 month

  • Development of systemic inflammatory response syndrome (SIRS)

    Until hospital discharge or maximum of 1 month

  • 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

    Until hospital discharge or maximum of 1 month

  • +1 more secondary outcomes

Study Arms (2)

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

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

Drug: Ringer lactate

Interventions

Ringer lactateDRUG
Ringer lactate 20 mL/kgRinger lactate 40 ml/kg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with diagnosis of acute pancreatitis.

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHRijeka

Rijeka, Rijeka, 51000, Croatia

RECRUITING

Related Publications (33)

  • 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.

    PMID: 9015927BACKGROUND

  • Cuthbertson CM, Christophi C. Disturbances of the microcirculation in acute pancreatitis. Br J Surg. 2006 May;93(5):518-30. doi: 10.1002/bjs.5316.

    PMID: 16607683BACKGROUND

  • Zhao 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.

    PMID: 23599623BACKGROUND

  • Tenner 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.

    PMID: 23896955BACKGROUND

  • Bradley 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.

    PMID: 8489394BACKGROUND

  • Vege 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.

    PMID: 15825098BACKGROUND

  • Thoeni 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.

    PMID: 22357880BACKGROUND

  • Vege 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.

    PMID: 19262525BACKGROUND

  • Petrov 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.

    PMID: 19844203BACKGROUND

  • Banks 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.

    PMID: 23100216BACKGROUND

  • Ranson 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.

    PMID: 4834279BACKGROUND

  • Blamey 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.

    PMID: 6510766BACKGROUND

  • Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.

    PMID: 3928249BACKGROUND

  • Singh 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.

    PMID: 19293787BACKGROUND

  • Balthazar EJ. Staging of acute pancreatitis. Radiol Clin North Am. 2002 Dec;40(6):1199-209. doi: 10.1016/s0033-8389(02)00047-7.

    PMID: 12479706BACKGROUND

  • Juneja D, Gopal PB, Ravula M. Scoring systems in acute pancreatitis: which one to use in intensive care units? J Crit Care. 2010 Jun;25(2):358.e9-358.e15. doi: 10.1016/j.jcrc.2009.12.010. Epub 2010 Feb 10.

    PMID: 20149591BACKGROUND

  • Schutte K, Malfertheiner P. Markers for predicting severity and progression of acute pancreatitis. Best Pract Res Clin Gastroenterol. 2008;22(1):75-90. doi: 10.1016/j.bpg.2007.10.013.

    PMID: 18206814BACKGROUND

  • Wu BU, Johannes RS, Sun X, Tabak Y, Conwell DL, Banks PA. The early prediction of mortality in acute pancreatitis: a large population-based study. Gut. 2008 Dec;57(12):1698-703. doi: 10.1136/gut.2008.152702. Epub 2008 Jun 2.

    PMID: 18519429BACKGROUND

  • Haydock MD, Mittal A, van den Heever M, Rossaak JI, Connor S, Rodgers M, Petrov MS, Windsor JA; Pancreas Network of New Zealand. National survey of fluid therapy in acute pancreatitis: current practice lacks a sound evidence base. World J Surg. 2013 Oct;37(10):2428-35. doi: 10.1007/s00268-013-2105-7.

    PMID: 23720122BACKGROUND

  • Khajavi MR, Etezadi F, Moharari RS, Imani F, Meysamie AP, Khashayar P, Najafi A. Effects of normal saline vs. lactated ringer's during renal transplantation. Ren Fail. 2008;30(5):535-9. doi: 10.1080/08860220802064770.

    PMID: 18569935BACKGROUND

  • Wu BU, Hwang JQ, Gardner TH, Repas K, Delee R, Yu S, Smith B, Banks PA, Conwell DL. Lactated Ringer's solution reduces systemic inflammation compared with saline in patients with acute pancreatitis. Clin Gastroenterol Hepatol. 2011 Aug;9(8):710-717.e1. doi: 10.1016/j.cgh.2011.04.026. Epub 2011 May 12.

    PMID: 21645639BACKGROUND

  • Nasr JY, Papachristou GI. Early fluid resuscitation in acute pancreatitis: a lot more than just fluids. Clin Gastroenterol Hepatol. 2011 Aug;9(8):633-4. doi: 10.1016/j.cgh.2011.03.010. Epub 2011 Mar 21. No abstract available.

    PMID: 21421079BACKGROUND

  • Warndorf MG, Kurtzman JT, Bartel MJ, Cox M, Mackenzie T, Robinson S, Burchard PR, Gordon SR, Gardner TB. Early fluid resuscitation reduces morbidity among patients with acute pancreatitis. Clin Gastroenterol Hepatol. 2011 Aug;9(8):705-9. doi: 10.1016/j.cgh.2011.03.032. Epub 2011 Apr 8.

    PMID: 21554987BACKGROUND

  • Wall I, Badalov N, Baradarian R, Iswara K, Li JJ, Tenner S. Decreased mortality in acute pancreatitis related to early aggressive hydration. Pancreas. 2011 May;40(4):547-50. doi: 10.1097/MPA.0b013e318215368d.

    PMID: 21499208BACKGROUND

  • Stimac D, Poropat G. Rational therapy of acute pancreatitis. Dig Dis. 2010;28(2):310-6. doi: 10.1159/000319406. Epub 2010 Sep 1.

    PMID: 20814204BACKGROUND

  • Tenner S. Initial management of acute pancreatitis: critical issues during the first 72 hours. Am J Gastroenterol. 2004 Dec;99(12):2489-94. doi: 10.1111/j.1572-0241.2004.40329.x.

    PMID: 15571599BACKGROUND

  • Aggarwal A, Manrai M, Kochhar R. Fluid resuscitation in acute pancreatitis. World J Gastroenterol. 2014 Dec 28;20(48):18092-103. doi: 10.3748/wjg.v20.i48.18092.

    PMID: 25561779BACKGROUND

  • ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

    PMID: 22797452BACKGROUND

  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) adopts Consolidated Guideline on Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use. Int Dig Health Legis. 1997;48(2):231-4. No abstract available.

    PMID: 11656783BACKGROUND

  • Werner J, Hartwig W, Uhl W, Muller C, Buchler MW. Useful markers for predicting severity and monitoring progression of acute pancreatitis. Pancreatology. 2003;3(2):115-27. doi: 10.1159/000070079.

    PMID: 12748420BACKGROUND

  • Isenmann R, Runzi M, Kron M, Kahl S, Kraus D, Jung N, Maier L, Malfertheiner P, Goebell H, Beger HG; German Antibiotics in Severe Acute Pancreatitis Study Group. Prophylactic antibiotic treatment in patients with predicted severe acute pancreatitis: a placebo-controlled, double-blind trial. Gastroenterology. 2004 Apr;126(4):997-1004. doi: 10.1053/j.gastro.2003.12.050.

    PMID: 15057739BACKGROUND

  • Banks PA, Freeman ML; Practice Parameters Committee of the American College of Gastroenterology. Practice guidelines in acute pancreatitis. Am J Gastroenterol. 2006 Oct;101(10):2379-400. doi: 10.1111/j.1572-0241.2006.00856.x. No abstract available.

    PMID: 17032204BACKGROUND

  • Khan AA, Parekh D, Cho Y, Ruiz R, Selby RR, Jabbour N, Genyk YS, Mateo R. Improved prediction of outcome in patients with severe acute pancreatitis by the APACHE II score at 48 hours after hospital admission compared with the APACHE II score at admission. Acute Physiology and Chronic Health Evaluation. Arch Surg. 2002 Oct;137(10):1136-40. doi: 10.1001/archsurg.137.10.1136.

    PMID: 12361419BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Vanja Giljača, M.D. PhD

    University Hospital Rijeka

    STUDY CHAIR

Central Study Contacts

Vanja Giljača, M.D. PhD

CONTACT

+38551658885vanja.giljača@gmail.com

Petra Šverko, M.D.

CONTACT

+38598247655petrasverko@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. PhD

Study Record Dates

First Submitted

March 10, 2016

First Posted

March 15, 2016

Study Start

February 1, 2016

Primary Completion

March 1, 2018

Study Completion

September 1, 2018

Last Updated

March 15, 2016

Record last verified: 2016-03

Locations

CR(1)