Dextran 40 Plus Ringer's Lactate Vs. Ringer's Lactate Alone for Fluid Resuscitation in Acute Pancreatitis

NCT06835023 | Recruiting

• 2 other identifiers: CE15/14.10.202127/11.10.2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to learn if a combination of Dextran 40 and Ringer's lactate solution can improve fluid resuscitation in mild and moderate acute pancreatitis (AP) and prevent complications. The main questions it aims to answer are: Does early fluid resuscitation with Dextran 40 plus Ringer's lactate improve patient outcomes compared to Ringer's alone? Does this treatment reduce inflammation, organ failure, and the need for intensive care unit (ICU) admission? Researchers will compare Dextran 40 plus Ringer's lactate to Ringer's alone to see if the combination therapy is more effective in reducing disease severity and complications. Participants will: Receive either Dextran 40 plus Ringer's lactate (1:3 ratio) or Ringer's lactate alone. Have blood tests every 24 hours to measure inflammation and organ function. Be monitored for changes in disease severity, need for ICU admission, and hospitalization duration. This study will help determine the best fluid resuscitation strategy for treating mild and moderate acute pancreatitis.

Conditions

Acute Pancreatitis (AP); Acute Pancreatic Fluid Collection; Fluid Resuscitation

Keywords

Fluid resuscitation; Acute pancreatitis; Dextran; Ringer Lactat solution; combination colloid-crystalloid

Outcome Measures

Primary Outcomes (2)

• roportion of Participants with Resolution of Systemic Inflammatory Response Syndrome (SIRS)

  The percentage of participants who experience resolution of SIRS, defined as meeting ≤1 of the SIRS criteria (body temperature, heart rate, respiratory rate, and white blood cell count) for two consecutive 24-hour assessments. SIRS Criteria: * Body temperature \<36°C or \>38°C * Heart rate \>90 beats per minute * Respiratory rate \>20 breaths per minute or PaCO₂ \<32 mmHg * White blood cell count \<4,000 cells/mm³ or \>12,000 cells/mm³ Data Collection \& Aggregation: * SIRS criteria will be assessed every 24 hours. * The percentage of participants achieving SIRS resolution by Day 4 or discharge will be reported. Unit of Measure: Percentage of participants achieving SIRS resolution.

  From enrollment (Day 1) to Day 4 or discharge, whichever occurs first.

• Mean Percentage Reduction in Serum C-Reactive Protein (CRP) Levels (mg/L) from Baseline

  Serum C-Reactive Protein (CRP) will be measured in milligrams per liter (mg/L) at baseline (Day 1) and then every 24 hours until Day 4 or discharge. The outcome will be calculated as the mean percentage reduction in CRP from baseline to the final recorded value. CRP measurements will be performed using standardized high-sensitivity assays Unit of Measure: Mean percentage reduction in CRP levels (mg/L).

  Baseline (Day 1) to Day 4 or discharge, whichever occurs first

Study Arms (2)

Dextran 40 plus Ringer Lactat 1:3 ratio

EXPERIMENTAL

50 patients with acute pancreatitis will receive Dextran 40 plus RInger Lactat 1:3 ratio early to admission in the hospital

Drug: Dextran+Ringer Lactat(D+RLS)

Ringer Lactat

ACTIVE COMPARATOR

50 patients will receive only Ringer Lactat

Drug: Ringer lactate (RLS)

Interventions

Ringer lactate (RLS) DRUG

50 patients will receive only Ringer Lactat

Ringer Lactat

Dextran+Ringer Lactat(D+RLS) DRUG

50 patients Dextran+RInger Lactat 1:3 ratio

Dextran 40 plus Ringer Lactat 1:3 ratio

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults (≥18 years) diagnosed with mild or moderate acute pancreatitis
• must provide written informed consent for study participation.

You may not qualify if:

• patients who decline to provide informed consent.
• patients are non-compliant with treatment and follow-up visits.
• pregnant individuals.
• patients requiring concomitant treatment that is contraindicated within the study protocol.
• patients who develop conditions that contraindicate the administration of the investigational medication.
• patients experiencing severe adverse reactions necessitating treatment discontinuation.

Sponsors & Collaborators

• Satu Mare County Emergency Hospital: lead

Study Sites (1)

Spitalul Judetean de Urgenta Satu Mare

Satu Mare, Satu Mare County, 440067, Romania

RECRUITING

MeSH Terms

Conditions

Pancreatitis

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Costea Cristian PHD STUDENT, MEDICNE

CONTACT

+40755874293; drcostecristian@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD STUDENT DOCTOR

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: February 19, 2025
• Study Start: January 10, 2022
• Primary Completion: May 12, 2025
• Study Completion: May 12, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 12 May 2025, until 12 May 2026

Locations

RO (1)