NCT04688645

Brief Summary

Patients diagnosed with acute pancreatitis regardless of etiology, severity of disease, and prior attacks will be randomized in two groups. The intervention group will receive a balanced crystalloid (Plasmalyte) at a rate of 10 ml/kg during the first 60 min and then continued at 3 ml/kg/h for the next 72 hours. The control group will receive normal saline at the same rate.

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
276

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2020

Typical duration for phase_4

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

May 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

2.6 years

First QC Date

December 23, 2020

Last Update Submit

December 29, 2020

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with New Onset Systemic inflammatory response syndrome (SIRS)

    Body temperature less than 36 °C (96.8 °F) or greater than 38 °C (100.4 °F); heart rate greater than 90 beats per minute; tachypnea (high respiratory rate), with greater than 20 breaths per minute or, an arterial partial pressure of carbon dioxide less than 4.3 kilopascals (32 mmHg); white blood cell count less than 4000 cells/mm³ (4 x 109 cells/L) or greater than 12,000 cells/mm³ (12 x 109 cells/L) or the presence of greater than 10% immature neutrophils.

    30 days

Secondary Outcomes (7)

  • Mortality

    30 days

  • Number of participants with organ failure (transitory and persistent)

    30 days

  • Number of participants with local complications

    30 days

  • Number od participants with systemic complications

    30 days

  • Number of participants with infected pancreatic necrosis

    30 days

  • +2 more secondary outcomes

Study Arms (2)

Balanced crystalloid solution

EXPERIMENTAL

Balanced crystalloid solution - Plasmalyte.

Drug: Balanced crystalloid solution

Normal saline

ACTIVE COMPARATOR

0.9% sodium chloride solution.

Drug: Normal saline

Interventions

Balanced crystalloid solutionDRUG

Balanced crystalloid solution (Plasmalyte) given as an initial bolus of 10 ml/kg body weight within the first 60 min after randomization, and then continued at a rate of 2 ml/kg body weight during the next 72 hours. If needed boluses may be repeated.

Also known as: Plasmalyte; balanced crystalloids
Balanced crystalloid solution
Normal salineDRUG

0.9% sodium chloride solution given as an initial bolus of 10 ml/kg body weight within the first 60 min after randomization, and then continued at a rate of 2 ml/kg body weight during the next 72 hours. If needed boluses may be repeated.

Also known as: Saline; 0.9% sodium chloride solution
Normal saline

Eligibility Criteria

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

You may qualify if:

  • \- patients diagnosed with acute pancreatitis based on the revised Atlanta criteria who present to our hospital within 48 hours of symptoms onset, regardless of etiology, severity of disease, or prior episodes of acute pancreatitis

You may not qualify if:

  • chronic pancreatitis
  • liver cirrhosis (Child-Pugh B and C)
  • chronic hearth failure (NYHA\>II)
  • acute coronary syndrome
  • cardiovascular intervention within 60 days before randomization
  • chronic obstructive pulmonary disease dependent of home oxygenator or acute exacerbation of chronic obstructive pulmonary disease
  • chronic kidney disease (eGFR \<30 ml/min/1.73 m2)
  • concomitant biliary infection (cholecystitis, cholangitis)
  • severe autoimmune disease
  • chronic active infection (TBC, AIDS)
  • metastatic malignant disease
  • primary pancreatic neoplasm
  • patients transferred from other hospitals
  • pregnancy and ongoing breastfeeding
  • not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Rijeka

Rijeka, 51000, Croatia

RECRUITING

MeSH Terms

Conditions

Pancreatitis

Interventions

Plasmalyte ASaline SolutionSodium Chloride

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Goran Poropat, MD, PhD

CONTACT

0038551658191gporopat8@gmail.com

Anja Radovan, MD

CONTACT

0038551658111anja.radovan@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

December 23, 2020

First Posted

December 30, 2020

Study Start

May 1, 2020

Primary Completion

December 1, 2022

Study Completion

February 1, 2023

Last Updated

December 30, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)