Actively Recruiting
A Randomized Controlled Trial Evaluating Fluid Resuscitation in Acute Pancreatitis: Dextran 40 and Ringer's Lactate (1:3 Ratio) Versus Ringer's Lactate Alone
Led by Satu Mare County Emergency Hospital · Updated on 2025-02-20
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a combination of Dextran 40 and Ringer's lactate solution improves fluid resuscitation in adults with mild and moderate acute pancreatitis compared to Ringer's lactate alone. The study aims to find out if this combined treatment reduces inflammation, organ failure, and the need for intensive care. This randomized controlled trial involves about 100 patients at a hospital setting to better understand the best approach for fluid management in acute pancreatitis. Participants will receive either a mix of Dextran 40 and Ringer's lactate in a 1:3 ratio or only Ringer's lactate, administered at a rate of 1.5 mL per kilogram per hour, adjusted to each patient's condition. The study interventions are given early after hospital admission. The trial compares the two treatments to see which better prevents disease progression and complications. During the study, patients will have blood tests every 24 hours to monitor pancreatic enzymes, inflammation markers like C-reactive protein, and organ function. Ultrasound will assess central venous pressure, and urine output will be tracked as a sign of adequate resuscitation. The main outcomes measured include reduction of systemic inflammatory response syndrome (SIRS) and C-reactive protein levels from admission to day 4 or discharge. Patients will be observed during their hospital stay and followed up 12 weeks after discharge to assess longer-term effects.
CONDITIONS
Brief Title
Dextran 40 Plus Ringer's Lactate Vs. Ringer's Lactate Alone for Fluid Resuscitation in Acute Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (18 years or older) diagnosed with mild or moderate acute pancreatitis
- Must provide written informed consent for study participation
You will not qualify if you...
- Patients who decline to provide informed consent
- Patients non-compliant with treatment and follow-up visits
- Pregnant individuals
- Patients requiring treatments contraindicated in this study protocol
- Patients who develop conditions preventing use of the study medication
- Patients with severe adverse reactions requiring stopping treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 days or until hospital discharge, whichever occurs first
Participants receive fluid resuscitation with either Dextran 40 plus Ringer's lactate solution (1:3 ratio) or Ringer's lactate alone to manage acute pancreatitis and prevent disease progression.
Daily assessments during hospitalization
Duration - 12 weeks post-discharge
Participants are monitored for outcomes including recovery and any complications up to 12 weeks after discharge.
1 follow-up visit (in-person) at 12 weeks post-discharge
Trial Site Locations
Total: 1 location
1
Spitalul Judetean de Urgenta Satu Mare
Satu Mare, Satu Mare County, Romania, 440067
Actively Recruiting
Research Team
C
Costea Cristian PHD STUDENT, MEDICNE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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