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

Sponsor

Changhai Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05772234

Collaborator

(none)

1,066

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatitis, Chronic Pancreatic Duct Stone	Drug: Lactated ringers solution Drug: normal saline	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1066 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Incidence of post-ESWL pancreatitis [48 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.

Secondary Outcome Measures

Severity of pancreatitis [1 month]
Stratified as mild, moderate, or severe, mainly on the basis of length of hospitalization and need for invasive treatment.
Incidence of other post-ESWL complications [48 hours]
Including bleeding, infection, steinstrasse, and perforation.
Incidence of fluid overload [48 hours]
Including pulmonary or peripheral edema and congestive heart failure.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Patients readmitted to the hospital for ESWL during the study period.
Acute pancreatitis in the last 3 days.
Signs of congestive heart failure, such as pitting edema or a New York Heart Association classification greater than class I heart failure.
Respiratory insufficiency (pO2 < 60 mmHg or saturation < 90% despite FiO2 of 30% or requiring mechanical ventilation).
Severe liver disease (cirrhosis, liver abscess).
Patients receiving more than 1.5 mL/kg/h or 3 L/24 h of intravenous fluids in the 24 h before ESWL.
Hypotension (systolic blood pressure <90 mmHg or mean arterial pressure <70 mmHg).
Hypo- or hypernatremia (serum Na+ levels < 130 or > 150 mmol/L).
Pregnancy.
Unwilling or unable to provide consent.