Intravenous Fluids for Acute Pancreatitis Prevention

(STRIPE Trial)

Overseen By Nauzer Forbes, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Calgary

Disqualifiers: Heart failure, Renal insufficiency, Cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

505 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Intravenous Ringer's lactate for preventing acute pancreatitis?

Research shows that using Lactated Ringer's solution for fluid resuscitation in patients with acute pancreatitis can lead to better outcomes compared to normal saline. Studies indicate that it may reduce the risk of developing more severe forms of the condition. ^{1 2 3 4 5}

Is Lactated Ringer's solution safe for humans?

The provided research articles do not contain safety data specifically about Lactated Ringer's solution or its use in humans. ^{6 7 8 9 10}

How is the treatment with Lactated Ringer's solution different for acute pancreatitis?

Lactated Ringer's solution is a type of intravenous fluid that is often preferred over normal saline for treating acute pancreatitis because it may lead to better outcomes, such as reducing the risk of severe pancreatitis. It is unique because it is a buffered solution, which means it can help maintain a more balanced pH in the body compared to normal saline. ^{1 3 4 5 11}

What is the purpose of this trial?

This study will explore the efficacies of several practical short-term (peri-procedural) intravenous fluid regimens in the prevention of post- endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). PEP is the most common serious ERCP-related adverse event (AE), occurring in 5-15% of patients, and associated with significant morbidity, mortality, and healthcare utilization. Given the current lack of data on effectiveness of short-term fluid regimens in PEP prevention to inform practice, the results of the proposed study have the strong potential to impact ERCP practices worldwide, whether positive or negative.

Eligibility Criteria

This trial is for individuals aged 18-75 who can consent to treatment, have their original major papillary anatomy intact, and are willing to get bloodwork done the day after an ERCP procedure. It's not suitable for those with undiagnosed heart or kidney issues often found in people over 75.

Inclusion Criteria

I understand the study and can agree to participate.

I can and will get blood tests the day after my ERCP procedure.

My kidney structure is normal.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive short-term intravenous fluid regimens peri-procedurally to prevent post-ERCP pancreatitis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including monitoring for adverse events such as pancreatitis, cholangitis, and bleeding

30 days

Treatment Details

Interventions

• Intravenous Ringer's lactate

Trial Overview The study is testing how effective different short-term intravenous fluid regimens are at preventing pancreatitis after an ERCP procedure. Specifically, it's looking at Intravenous Ringer's lactate given around the time of the procedure.

Participant Groups

Group I: Ringer's lactate 2500 cc IV Experimental Treatment 1 Intervention

Group II: Ringer's lactate 2000 cc IV Experimental Treatment 1 Intervention

Group III: Ringer's lactate 1500 cc IV Experimental Treatment 1 Intervention

Group IV: Ringer's lactate 1000 cc IV Experimental Treatment 1 Intervention

Group V: Ringer's lactate 500 cc IV Active Control 1 Intervention

Intravenous Ringer's lactate is already approved in European Union, United States for the following indications:

Approved in European Union as Ringer's lactate for:

• Prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis

Approved in United States as Lactated Ringer's solution for:

• Prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Findings from Research

In a study of 20,049 veterans hospitalized for acute pancreatitis, using Lactated Ringer's (LR) solution for initial fluid resuscitation was linked to a significant reduction in 1-year mortality compared to normal saline (NS), with an adjusted odds ratio of 0.61.

While major complications and early mortality rates were similar between the two groups, the findings suggest that LR may be a more beneficial choice for fluid resuscitation in patients with acute pancreatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lactated Ringer's or Normal Saline for Initial Resuscitation in Patients Hospitalized With Acute Pancreatitis: A Retrospective Database Analysis. Antoniak, D., Twohig, P., Olson, K., et al.[2023]

In a systematic review and meta-analysis of randomized controlled trials, lactated Ringer's (LR) solution significantly reduced the odds of intensive care unit admission in patients with acute pancreatitis compared to normal saline (NS), with a pooled odds ratio of 0.33.

LR also led to a lower likelihood of developing local complications in these patients, with a pooled odds ratio of 0.43, suggesting it may be a better fluid choice for managing acute pancreatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluid Resuscitation With Lactated Ringer's Solution Versus Normal Saline in Acute Pancreatitis: A Systematic Review and Meta-Analysis of Randomized Trials. Kow, CS., Burud, IAS., Hasan, SS.[2023]

In a study involving 999 patients with acute pancreatitis, the use of lactated ringers (LR) in the first 24 hours was linked to a 48% reduction in the odds of developing moderately severe or severe acute pancreatitis compared to normal saline.

These findings suggest that LR may be a safer and more effective fluid choice for initial treatment in acute pancreatitis, but further large-scale randomized clinical trials are necessary to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lactated Ringers Use in the First 24 Hours of Hospitalization Is Associated With Improved Outcomes in 999 Patients With Acute Pancreatitis. Lee, PJ., Culp, S., Kamal, A., et al.[2023]

In a meta-analysis of five randomized controlled trials involving 370 patients with mild acute pancreatitis, an aggressive intravenous hydration protocol using Lactated Ringer's solution showed a significant reduction in the rates of systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS) compared to standard hydration protocols.

Patients receiving aggressive hydration also experienced greater relief from epigastric abdominal pain and had shorter hospital stays, indicating potential benefits in clinical outcomes, although the overall evidence quality was low to moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aggressive intravenous hydration protocol of Lactated Ringer's solution benefits patients with mild acute pancreatitis: A meta-analysis of 5 randomized controlled trials. Wu, F., She, D., Ao, Q., et al.[2023]

A meta-analysis of four randomized controlled trials involving 248 patients found that lactated Ringer's solution (LR) may be more effective than normal saline (NS) in reducing the need for intensive care unit admission in patients with acute pancreatitis (AP).

While there were no significant differences between LR and NS in terms of systemic inflammatory response syndrome, in-hospital mortality, or other complications, LR showed a potential advantage in decreasing the incidence of pancreatic necrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lactated Ringer Solution Is Superior to Normal Saline Solution in Managing Acute Pancreatitis: An Updated Meta-analysis of Randomized Controlled Trials. Chen, H., Lu, X., Xu, B., et al.[2023]

The study successfully matched 29% of poison center records to VAERS records, indicating a feasible method for linking vaccine exposure data across these two surveillance systems, despite the lack of unique identifiers.

The match rate varied by vaccine type, with the highest rates for diphtheria-pertussis-tetanus (49%) and influenza (42%), suggesting that certain vaccines may have more reported adverse events that are captured in both databases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of matching vaccine adverse event reporting system and poison center records. Forrester, MB.[2013]

The Vaccine Adverse Event Reporting System (VAERS) is a reliable database for assessing vaccine safety, with a good positive predictive value confirmed by multiple studies.

VAERS will play a crucial role in monitoring the safety of new or significantly modified vaccines that are expected to be introduced soon.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the Vaccine Adverse Event Reporting System database. Geier, DA., Geier, MR.[2019]

Out of 395 reported cases of anaphylaxis following vaccination with H1N1 vaccines Pandemrix™ and Arepanrix™, only 24.6% were confirmed cases, indicating challenges in accurately diagnosing anaphylaxis in post-vaccination settings.

The study found no increased rate of anaphylaxis for these vaccines compared to other vaccines, suggesting that the safety profile of Pandemrix™ and Arepanrix™ is consistent with that of other vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaphylaxis following H1N1 pandemic vaccines: safety data in perspective. Tavares, F., Delaigle, A., Slavin, D., et al.[2011]

The study found that the Vaccine Adverse Event Reporting System (VAERS) had a reporting completeness of only 47% for cases of intussusception following rotavirus vaccination, indicating that many adverse events may go unreported.

The analysis revealed significantly increased relative risks of intussusception shortly after vaccination (22.7 times higher in the 3-7 days post-vaccination), suggesting a need for improved monitoring and assessment of vaccine safety through enhanced data linkage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing vaccine safety surveillance: a capture-recapture analysis of intussusception after rotavirus vaccination. Verstraeten, T., Baughman, AL., Cadwell, B., et al.[2019]

In a safety surveillance study of the Vaxigrip and Intanza 15 µg influenza vaccines during the 2016/17 season, 1.8% of Vaxigrip recipients and 2.1% of Intanza recipients reported suspected adverse reactions within 7 days, indicating a generally low incidence of side effects.

The safety profiles of both vaccines remained consistent with previous years, with no significant increase in adverse reactions, suggesting that both vaccines are safe for use in the population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Report from enhanced safety surveillance of two influenza vaccines (Vaxigrip and Intanza 15 μg) in two European countries during influenza season 2016/17 and comparison with 2015/16 season. Chabanon, AL., Bricout, H., Ballandras, C., et al.[2019]

Recent studies indicate that aggressive fluid resuscitation in acute pancreatitis can lead to higher mortality and severe adverse events, suggesting a shift towards moderate fluid rates for better patient outcomes.

Ringer lactate solution has been found to be more effective than normal saline in managing fluid therapy for acute pancreatitis, highlighting the importance of choosing the right type of fluid in treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on the strategy for intravenous fluid treatment in acute pancreatitis. Yaowmaneerat, T., Sirinawasatien, A.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Lactated Ringer's or Normal Saline for Initial Resuscitation in Patients Hospitalized With Acute Pancreatitis: A Retrospective Database Analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Fluid Resuscitation With Lactated Ringer's Solution Versus Normal Saline in Acute Pancreatitis: A Systematic Review and Meta-Analysis of Randomized Trials. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Lactated Ringers Use in the First 24 Hours of Hospitalization Is Associated With Improved Outcomes in 999 Patients With Acute Pancreatitis. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Aggressive intravenous hydration protocol of Lactated Ringer's solution benefits patients with mild acute pancreatitis: A meta-analysis of 5 randomized controlled trials. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Lactated Ringer Solution Is Superior to Normal Saline Solution in Managing Acute Pancreatitis: An Updated Meta-analysis of Randomized Controlled Trials. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Feasibility of matching vaccine adverse event reporting system and poison center records. [2013]

7. England pubmed.ncbi.nlm.nih.gov

A review of the Vaccine Adverse Event Reporting System database. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Anaphylaxis following H1N1 pandemic vaccines: safety data in perspective. [2011]

9. United States pubmed.ncbi.nlm.nih.gov

Enhancing vaccine safety surveillance: a capture-recapture analysis of intussusception after rotavirus vaccination. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Report from enhanced safety surveillance of two influenza vaccines (Vaxigrip and Intanza 15 μg) in two European countries during influenza season 2016/17 and comparison with 2015/16 season. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Update on the strategy for intravenous fluid treatment in acute pancreatitis. [2023]