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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests varying amounts of intravenous Ringer's lactate fluids to determine their effectiveness in preventing pancreatitis (painful inflammation of the pancreas) after an ERCP procedure, which can sometimes cause this condition. Participants will receive one of several fluid amounts to identify the most effective option. Individuals who have undergone an ERCP without complications like pancreatitis in the past week may be suitable candidates. The results could influence global practices for preventing pancreatitis after ERCPs. As a Phase 4 trial, this research explores how an already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for Ringer's lactate?

Research has shown that Lactated Ringer's solution is usually safe for people. It can reduce the severity and risk of death in acute pancreatitis, an inflammation of the pancreas. This suggests it could be a safe option for individuals with similar health issues.

Some studies tested large amounts of Lactated Ringer's solution, up to 7.8 liters, without causing serious side effects. This indicates that smaller amounts, like those used in trials, should be even safer.

Overall, evidence supports Lactated Ringer's solution as a safe choice to help prevent complications after certain medical procedures. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using intravenous Ringer's lactate for preventing acute pancreatitis because it could offer a unique approach compared to traditional treatments like pain relief, fasting, and hydration with normal saline. Ringer's lactate is an IV fluid that includes electrolytes similar to those in your body's plasma, which can help reduce inflammation more effectively. This makes it potentially more beneficial in maintaining the body's fluid balance and reducing the risk of further pancreatic damage. Moreover, this trial explores different doses of Ringer's lactate, which could help pinpoint the most effective volume for acute pancreatitis prevention.

What evidence suggests that this trial's intravenous fluid regimens could be effective for preventing post-ERCP pancreatitis?

Research has shown that Ringer's lactate, administered through an IV, can help manage acute pancreatitis, a sudden inflammation of the pancreas. Studies have found that patients receiving Ringer's lactate were less likely to require intensive care than those given other fluids. This suggests that Ringer's lactate might help prevent serious complications. Compared to normal saline, Ringer's lactate is associated with better health outcomes and a lower risk of developing more severe pancreatitis. Additionally, using Ringer's lactate may improve recovery and reduce complications after procedures like ERCP, a test to examine the pancreas and bile ducts. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12468465/

Fluid Resuscitation with Lactated Ringer vs. Normal Saline in ... Results: Five trials with 299 patients showed that, in patients with AP, Lactated Ringer significantly reduced ICU admission (RR: 0.39; 95% CI: 0.18–0.85; p = ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2202884

Aggressive or Moderate Fluid Resuscitation in Acute ... Patients in the aggressive-resuscitation group received a median of 7.8 liters (interquartile range, 6.5 to 9.8) of lactated Ringer's solution ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12165476/

Lactated Ringer's solution versus saline fluid resuscitation for ... The results demonstrate that lactated Ringer's solution may be more effective than normal saline in reducing the incidence of moderate to ...

4. ccjm.org ccjm.org/content/91/8/466

What fluids should I order for my patient with acute ... Emerging data suggest that lactated Ringer's is associated with improved health outcomes and hence may be superior to normal saline in acute ...

5. jwatch.org jwatch.org/na56421/2023/09/05/lactated-ringers-superior-normal-saline-acute-pancreatitis

Is Lactated Ringer's Superior to Normal Saline in Acute ... This large observational study suggests that lactated Ringer's might prevent moderate-to-severe pancreatitis more effectively than normal saline.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9953296/

Lactated Ringer's Solution Reduces Severity, Mortality ... Lactated Ringer's Solution Reduces Severity, Mortality, Systemic and Local Complications in Acute Pancreatitis: A Systematic Review and Meta-Analysis.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03642769

Lactated Ringer's Versus Normal Saline for Acute ... The objective of this study is to assess the comparative efficacy of normal saline versus lactated ringer's solution in the management of acute pancreatitis.

8. withpower.com withpower.com/trial/phase-4-post-ercp-acute-pancreatitis-8-2024-e4da7

Intravenous Fluids for Acute Pancreatitis Prevention 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 ...