A Randomized Controlled Trial Evaluating Fluid Resuscitation in Acute Pancreatitis: Dextran 40 and Ringer's Lactate (1:3 Ratio) Versus Ringer's Lactate Alone
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- roportion of Participants with Resolution of Systemic Inflammatory Response Syndrome (SIRS)
Study Overview
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.
Detailed Description
Detailed Description Acute pancreatitis (AP) is a common gastrointestinal disorder requiring hospitalization, with an incidence of approximately 40 cases per 100,000 individuals. The severity of AP ranges from mild to severe, with 15-20% of cases progressing to severe acute pancreatitis (SAP), which is characterized by organ failure and local complications. The mortality rate for severe acute pancreatitis remains high, reaching 20-30%, highlighting the critical need for early and adequate fluid resuscitation in emergency settings.
Despite universal recommendations for early-volume resuscitation, there is no clear consensus regarding the optimal fluid type, infusion rate, total volume, or monitoring strategy. Fluid resuscitation's primary objective is to prevent or minimize systemic inflammatory response syndrome (SIRS), which significantly contributes to AP progression.
This randomized controlled trial (RCT) will compare the effectiveness of a colloid-crystalloid combination (Dextran 40 in sodium chloride [NaCl] 0.9 grams per liter [g/L] solution and Ringer's lactate solution in a 1:3 ratio) versus Ringer's lactate solution alone in preventing disease progression and reducing complications in patients with mild or moderate AP.
Study Design This randomized clinical trial (RCT) will be conducted at Satu Mare County Emergency Hospital and enroll approximately 100 patients diagnosed with mild or moderate AP.
Fluid Administration Rate: 1,5 mL/kg/h, based on patient hemodynamic status.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Dextran 40 plus Ringer Lactat 1:3 ratio
50 patients with acute pancreatitis will receive Dextran 40 plus RInger Lactat 1:3 ratio early to admission in the hospital
Intervention: Dextran+Ringer Lactat(D+RLS) (Drug)
Ringer Lactat
50 patients will receive only Ringer Lactat
Intervention: Ringer lactate (RLS) (Drug)
Outcomes
Primary Outcomes
roportion of Participants with Resolution of Systemic Inflammatory Response Syndrome (SIRS)
Time Frame: From enrollment (Day 1) to Day 4 or discharge, whichever occurs first.
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.
Mean Percentage Reduction in Serum C-Reactive Protein (CRP) Levels (mg/L) from Baseline
Time Frame: Baseline (Day 1) to Day 4 or discharge, whichever occurs first
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
COSTEA CRISTIAN
PHD STUDENT DOCTOR
Satu Mare County Emergency Hospital