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

NCT ID: NCT06835023

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2025-05-12

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.

• Data Collection and Assessment
• Clinical and Demographic Data:
• Age, sex.
• Lifestyle factors (alcohol consumption, smoking).
• Symptom onset time and severity classification (based on the Revised Atlanta -Classification, 2012).

=Diagnostic Criteria (Requires ≥2 of 3):

• Acute upper abdominal pain.
• Serum amylase/lipase levels ≥3 times the upper standard limit (ULN).
• Imaging findings (CT, ultrasound, or MRI) consistent with AP.

Organ Failure Assessment:

-Modified Marshall Scoring System (2012).

Severity Scoring:

• Modified Glasgow Score.
• Acute Physiology and Chronic Health Evaluation II (APACHE II).
• Bedside Index for Severity in Acute Pancreatitis (BISAP).
• CT Severity Index.

Laboratory Biomarkers & Monitoring

Blood samples will be collected at admission and every 24 hours to assess:

• Pancreatic Enzymes: Amylase, lipase.
• Inflammatory Markers & Organ Function Parameters:
• C-reactive protein (CRP).
• Erythrocyte sedimentation rate (ESR).
• Hematocrit.
• Urea, creatinine.
• Systemic inflammatory response syndrome (SIRS) markers.
• Fibrinogen, ferritin.
• Procalcitonin at enrollment and 72 hours.

Additional Monitoring:

An ultrasound will measure the Inferior vena cava (IVC) diameter and collapsibility index to estimate central venous pressure (CVP) and hemodynamic status.

Urine output every 24 hours (target ≥0.5 mL/kg/h as an adequate resuscitation marker).

Primary and Secondary Outcome Measures

Primary Outcomes:

Reduction in C-reactive protein (CRP) and SIRS

Secondary Outcomes:

• Reduced duration of hospitalization and lower ICU admission rates.
• Reduction of erythrocyte sedimentation rate (ESR) and other inflammatory markers.
• Complication rates (e.g., pancreatic necrosis, organ failure).
• Hospitalization costs.
• In-hospital mortality and follow-up mortality at 3 months.

Follow-up and Study Endpoints Patients will be monitored throughout hospitalization and followed up at 12 weeks post-discharge.

Expected Impact This study aims to identify the optimal fluid resuscitation strategy for mild and moderate AP. If the colloid-crystalloid combination proves superior, it could lead to changes in clinical guidelines for AP management, potentially reducing organ failure, ICU admissions, and mortality rates.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Dextran+Ringer Lactat(D+RLS)

Intervention Type: DRUG

50 patients Dextran+RInger Lactat 1:3 ratio

Ringer Lactat

50 patients will receive only Ringer Lactat

Group Type: ACTIVE_COMPARATOR

Ringer lactate (RLS)

Intervention Type: DRUG

50 patients will receive only Ringer Lactat

Interventions

Ringer lactate (RLS)

50 patients will receive only Ringer Lactat

Intervention Type: DRUG

Dextran+Ringer Lactat(D+RLS)

50 patients Dextran+RInger Lactat 1:3 ratio

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Satu Mare County Emergency Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

COSTEA CRISTIAN

PHD STUDENT DOCTOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Spitalul Judetean de Urgenta Satu Mare

Satu Mare, Satu Mare County, Romania

Site Status: RECRUITING

Countries

Romania

Central Contacts

Costea Cristian PHD STUDENT, MEDICNE

Role: CONTACT

drcostecristian@gmail.com

+40755874293

Facility Contacts

Costea Nicolae CRISTIAN, PHD STUDENT

Role: primary

drcosteacristian@gmail.com

+40755874293

Other Identifiers

27/11.10.2021

Identifier Type: OTHER

Identifier Source: secondary_id

CE15/14.10.2021

Identifier Type: -

Identifier Source: org_study_id