Acute Pancreatitis (AP)NCT06835023
Dextran 40 Plus Ringer's Lactate Vs. Ringer's Lactate Alone for Fluid Resuscitation in Acute Pancreatitis
A study testing Ringer lactate (RLS) and Dextran+Ringer Lactat(D+RLS) in people with Acute Pancreatitis (AP) and Acute Pancreatic Fluid Collection, run by Satu Mare County Emergency Hospital at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis (AP), Acute Pancreatic Fluid Collection, Fluid Resuscitation
- What is being tested?
- Ringer lactate (RLS) and Dextran+Ringer Lactat(D+RLS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRomania
- Study dates
- 10 Jan 2022to 12 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults (≥18 years) diagnosed with mild or moderate acute pancreatitis
- must provide written informed consent for study participation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
Spitalul Judetean de Urgenta Satu Mare
Satu Mare, Satu Mare County, 440067
Costea Nicolae CRISTIAN, PHD STUDENT, +40755874293, drcosteacristian@gmail.com
About this study
Official title: A Randomized Controlled Trial Evaluating Fluid Resuscitation in Acute Pancreatitis: Dextran 40 and Ringer's Lactate (1:3 Ratio) Versus Ringer's Lactate Alone
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.
Read more
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.
Read the 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.
- Being tested
- Ringer lactate (RLS), Dextran+Ringer Lactat(D+RLS)
- Keywords
- Fluid resuscitation, Acute pancreatitis, Dextran, Ringer Lactat solution, combination colloid-crystalloid
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer lactate (RLS)Drug
50 patients will receive only Ringer Lactat
Dextran+Ringer Lactat(D+RLS)Drug
50 patients Dextran+RInger Lactat 1:3 ratio
| Study group | Role | What they receive |
|---|---|---|
| Dextran 40 plus Ringer Lactat 1:3 ratio | Experimental | 50 patients with acute pancreatitis will receive Dextran 40 plus RInger Lactat 1:3 ratio early to admission in the hospital Receives: Drug: Dextran+Ringer Lactat(D+RLS) |
| Ringer Lactat | Active comparator | 50 patients will receive only Ringer Lactat Receives: Drug: Ringer lactate (RLS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment (Day 1) to Day 4 or discharge, whichever occurs first.
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).
Measured: Baseline (Day 1) to Day 4 or discharge, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start10 Jan 2022
- Primary completion12 May 2025 (estimated)
- Study completion12 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pancreatitis (AP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Satu Mare County Emergency Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, COSTEA CRISTIAN, Satu Mare County Emergency Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835023
- Sponsor's protocol ID
- CE15/14.10.2021
- Other IDs
- 27/11.10.2021
- Status last verified
- Feb 2025
- First submitted
- 1 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patients will be randomized into two groups: Experimental group: Dextran 40 in hypertonic saline + Ringer's lactate (1:3 ratio), in addition to standard treatment. Control group: Ringer's lactate alone, in addition to standard treatment. Fluids will be administered at a controlled hydration rate (5-10 mL/kg/h).
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating Fluid Resuscitation in Acute Pancreatitis: Dextran 40 and Ringer's Lactate (1:3 Ratio) Versus Ringer's Lactate Alone
- ClinicalTrials.gov ID
- NCT06835023
- Acronym / sponsor ID
- CE15/14.10.2021
- Keywords
- Fluid resuscitation, Acute pancreatitis, Dextran, Ringer Lactat solution, combination colloid-crystalloid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Satu Mare County Emergency HospitalOther government
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 12 May 2025 (estimated)
- Study completion
- 12 May 2025 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dextran 40 plus Ringer Lactat 1:3 ratio | Experimental | Drug: Dextran+Ringer Lactat(D+RLS)50 patients with acute pancreatitis will receive Dextran 40 plus RInger Lactat 1:3 ratio early to admission in the hospital |
| Ringer Lactat | Active comparator | Drug: Ringer lactate (RLS)50 patients will receive only Ringer Lactat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults (≥18 years) diagnosed with mild or moderate acute pancreatitis
- must provide written informed consent for study participation.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ringer lactate (RLS)50 patients will receive only Ringer Lactat | Drug | Ringer Lactat |
| Dextran+Ringer Lactat(D+RLS)50 patients Dextran+RInger Lactat 1:3 ratio | Drug | Dextran 40 plus Ringer Lactat 1:3 ratio |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: Yes. Patients will be randomized into two groups: Experimental group: Dextran 40 in hypertonic saline + Ringer's lactate (1:3 ratio), in addition to standard treatment. Control group: Ringer's lactate alone, in addition to standard treatment. Fluids will be administered at a controlled hydration rate (5-10 mL/kg/h).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ringer lactate (RLS) and Dextran+Ringer Lactat(D+RLS) in people with Acute Pancreatitis (AP) and Acute Pancreatic Fluid Collection, run by Satu Mare County Emergency Hospital at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Costea Cristian PHD STUDENT, MEDICNE (+40755874293, drcostecristian@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.