Dextran 40 Plus Ringer's Lactate Vs. Ringer's Lactate Alone for Fluid Resuscitation in Acute Panc… (NCT06835023) | Clinical Trial Compass
RecruitingNot Applicable
Dextran 40 Plus Ringer's Lactate Vs. Ringer's Lactate Alone for Fluid Resuscitation in Acute Pancreatitis
Romania100 participantsStarted 2022-01-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* adults (≥18 years) diagnosed with mild or moderate acute pancreatitis
* must provide written informed consent for study participation.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
roportion of Participants with Resolution of Systemic Inflammatory Response Syndrome (SIRS)
Timeframe: From enrollment (Day 1) to Day 4 or discharge, whichever occurs first.
2
Mean Percentage Reduction in Serum C-Reactive Protein (CRP) Levels (mg/L) from Baseline
Timeframe: Baseline (Day 1) to Day 4 or discharge, whichever occurs first