Balanced Crystalloid Solutions for Acute Pancreatitis

Treatment With Balanced Crystalloid Solutions in the Early Phase of Acute Pancreatitis

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.

Study Overview

• Status: Unknown
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Drug: Balanced crystalloid solution; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 276
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Goran Poropat, MD, PhD; Phone Number: 0038551658191; Email: gporopat8@gmail.com
• Study Contact Backup: Name: Anja Radovan, MD; Phone Number: 0038551658111; Email: anja.radovan@gmail.com

Study Locations

• Croatia
  • Rijeka, Croatia, 51000
    • Recruiting
    • University Hospital Rijeka
    • Contact: Goran Poropat, MD, PhD; Phone Number: 0038551658379; Email: gporopat8@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Balanced crystalloid solution; Balanced crystalloid solution - Plasmalyte.	Drug: Balanced crystalloid solution; 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.; Other Names: Plasmalyte; balanced crystalloids
ACTIVE_COMPARATOR: Normal saline; 0.9% sodium chloride solution.	Drug: Normal saline; 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.; Other Names: Saline; 0.9% sodium chloride solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Number of death cases	30 days
Number of participants with organ failure (transitory and persistent)	Organ failure defined according to the modified Marshall criteria	30 days
Number of participants with local complications	Local complications including: acute peripancreatic fluid collection; acute necrotic collection; pseudocyst; walled-off necrosis	30 days
Number od participants with systemic complications	Worsening of existing concomitant diseases	30 days
Number of participants with infected pancreatic necrosis	Defined by positive cultures from fine-needle aspiration of necrotic tissue or by the combination of clinical deterioration with clinical signs of infection and presence of gas within the necrotic tissue on imaging in cases of culture-negative, but highly suspicious cases.	30 days
Number of participants needing endoscopic / percutaneous / surgical interventions	In cases when presence of local infection or local complications (i.e. collection compressing surrounding organs and causing symptoms) requires an intervention	30 days
Length of hospital stay	Number of days in hospital, from admission to discharge or death.	30 days

Collaborators and Investigators

• Sponsor: University Hospital Rijeka
• Collaborators: University of Rijeka

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): February 1, 2023

Study Registration Dates

• First Submitted: December 23, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (ACTUAL): December 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 29, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pharmaceutical Solutions
• Other Study ID Numbers: uniri-biomed-18-154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No