Aggressive Intravenous Hydration With Lactated Ringer's Solution for Prevention of Post-ESWL Pancreatitis (HYPER)

January 18, 2024 updated by: Zhaoshen Li, Changhai Hospital

Aggressive Intravenous Hydration With Lactated Ringer's Solution for Prevention of Post-ESWL Pancreatitis: A Multicenter, Prospective, Randomized Clinical Trial

The goal of this clinical trial is to clarify whether aggressive intravenous hydration with lactated Ringer's solution could reduce the incidence of post-ESWL pancreatitis in patients with chronic pancreatitis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic pancreatitis (CP) is a disease caused by genetic and environmental factors that lead to progressive fibrosis of the pancreatic tissue, resulting in irreversible damage to the structure and function of the pancreas. The incidence of pancreatic duct stones in CP is as high as 90%. Stones can lead to pancreatic duct obstruction, pancreatic parenchymal hypertension and ischemia, inducing frequent abdominal pain and accelerating the decline of pancreatic function, therefore, removal of pancreatic duct stones is important for relieving CP symptoms. For large stones and complex stones, pancreatic extracorporeal shock wave lithotripsy (P-ESWL) was recommended. Acute pancreatitis is the most common complication after P-ESWL with an incidence of 6.3-12.5%, which result in prolonged hospitalization, increased medical costs, and can be life-threatening.

There are few studies on the prevention of postoperative pancreatitis after P- ESWL. Only one prospective randomized controlled study found the role of NSAIDs in the prevention of acute pancreatitis after ESWL, and preoperative use of rectal indomethacin reduced post-ESWL pancreatitis from 12% to 9%. ERCP placement of pancreatic duct stent is one of the effective methods to prevent post-ERCP pancreatitis. However, studies have shown that pancreatic duct stenting before ESWL is not effective in preventing acute pancreatitis after P-ESWL. More research is needed in the prevention and treatment of pancreatitis after P-ESWL.

There have been more high-quality studies on the prevention of post-ERCP pancreatitis. In addition to NSAIDs, several prospective randomized controls have found that perioperative high-dose lactated Ringerolysis (LRS) hydration is effective in preventing acute pancreatitis after ERCP. In a meta-analysis, active hydration of LRS was found to reduce post-ERCP pancreatitis from 13% to 6%. Based on above findings, international guidelines recommend aggressive perioperative LRS hydration to reduce the risk of post-ERCP pancreatitis.

Previous studies have suggested various mechanisms leading to post-ERCP pancreatitis, including mechanical injury, chemical injury, hydrostatic injury, and infection. Given the potentially similar pathogenesis of postoperative pancreatitis, we propose to conduct a randomized controlled trial to investigate the efficacy of active hydration of lactated Ringer's solution for the prevention of post-ESWL pancreatitis.

Study Type

Interventional

Enrollment (Estimated)

1066

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

All patients with chronic pancreatitis aged between18 and 85 years who were eligible for treatment with ESWL for pancreatic stones were eligible for enrolment.

Exclusion Criteria:

  1. Patients readmitted to the hospital for ESWL during the study period.
  2. Acute pancreatitis in the last 3 days.
  3. Signs of congestive heart failure, such as pitting edema or a New York Heart Association classification greater than class I heart failure. For patients ≥ 70 years old, brain natriuretic peptide (BNP) and cardiac ultrasound would be performed before ESWL. Patients with BNP>100pg/ml or Ejection Fraction value<50% should be excluded.
  4. Respiratory insufficiency (pO2 < 60 mmHg or saturation < 90% despite FiO2 of 30% or requiring mechanical ventilation). For patients ≥ 70 years old, pulmonary function tests would be performed before ESWL. Patients with Forced Expiratory Volume in the first second (FEV1) <70% are excluded.
  5. Severe liver disease (cirrhosis, liver abscess).
  6. Patients receiving more than 1.5 mL/kg/h or 3 L/24 h of intravenous fluids in the 24 h before ESWL.
  7. Hypotension (systolic blood pressure <90 mmHg or mean arterial pressure <70 mmHg).
  8. Hypo- or hypernatremia (serum Na+ levels < 130 or > 150 mmol/L).
  9. Pregnancy.
  10. Unwilling or unable to provide consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aggressive hydration group
Periprocedural hydration with intravenous 20 mL/kg lactated Ringer's solution within 60 min from the start of ESWL (first shockwave delivered), directly followed by 3 mL/kg per h for 8 h.
Drug: Lactated ringers solution
Intravenous 20 mL/kg Ringer's lactate solution within 60 min from the start of ESWL, directly followed by 3 mL/kg per h for 8 h.
Active Comparator: Restricted hydration group
Periprocedural hydration with normal saline (maximum of 1.5mL/kg per h or 3L per 24h).
Drug: normal saline
Intravenous fluid infusion with normal saline (maximum of 1.5mL/kg per h or 3L per 24h).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of post-ESWL pancreatitis
Time Frame: 24 hours
Post-ESWL pancreatitis is defined according to the 2012 Atlanta criteria. A diagnosis of post-ESWL pancreatitis is made if two of three of the following criteria are met: pain consistent with pancreatitis; amylase or lipase of at least three times the upper normal limit within 24 h of the procedure; or characteristic findings on imaging.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of pancreatitis
Time Frame: 1 month
Stratified as mild, moderate, or severe, mainly on the basis of length of hospitalization and need for invasive treatment.
1 month
Incidence of other post-ESWL complications
Time Frame: 24 hours
Including bleeding, infection, steinstrasse, and perforation.
24 hours
Incidence of fluid overload
Time Frame: 24 hours
Including pulmonary or peripheral edema and congestive heart failure.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Collaborators

First People's Hospital of Hangzhou
LanZhou University
Peking Union Medical College Hospital
Qilu Hospital of Shandong University
Ruijin Hospital
The Third Xiangya Hospital of Central South University
The Second Affiliated Hospital of Baotou Medical College
Shanghai Pudong New Area Gongli Hospital
Affiliated Hospital of Yunnan University

Investigators

  • Principal Investigator: Lianghao Hu, M.D., Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

February 18, 2023

First Submitted That Met QC Criteria

March 15, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYPER20221204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatitis, Chronic

Clinical Trials on Lactated ringers solution

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe