Dextran 40 Plus Ringer's Lactate Vs. Ringer's Lactate Alone for Fluid Resuscitation in Acute Pancreatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSatu Mare County Emergency Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adults (≥18 years) diagnosed with mild or moderate acute pancreatitis
must provide written informed consent for study participation.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Ringer lactate (RLS)
Drug50 patients will receive only Ringer Lactat
Dextran+Ringer Lactat(D+RLS)
Drug50 patients Dextran+RInger Lactat 1:3 ratio
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Dextran 40 plus Ringer Lactat 1:3 ratioExperimental treatment 1 intervention
Group B: Ringer LactatActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
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
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).
Time frame
Baseline (Day 1) to Day 4 or discharge, whichever occurs firstSponsors and contacts
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Source ClinicalTrials.gov