Lactated Ringers vs Normal Saline in Patients With Acute Pancreatitis: A Bias-Adjusted Meta-analysis

This study aims to compare NS and LR in terms of outcomes in patients with acute pancreatitis while addressing the current methodological issues with available meta-analyses on the topic. Such comparison combined with bias adjustment will assist with identifying the optimal fluid rehydration therapy in acute pancreatitis, since most of the available data is conflicted around the topic. A database search will be conducted to identify studies comparing normal saline and ringer's lactate. Existing meta-analyses will be assessed. The results will be discussed in the light of their strengths and limitations and then any deficiencies will be addressed through a new synthesis as a final step of this umbrella review. The primary outcome will be SIRS at 24 hours. OR and 95% confidence intervals will be generated using the quality effects model. Heterogeneity will be evaluated using the I2 statistic. Publication bias will be assessed using the Doi Plot.

Study Overview

• Status: Recruiting
• Conditions: Acute Pancreatitis

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Suhail Doi; Phone Number: 0097444037854; Email: sdoi@qu.edu.qa

Study Locations

• Qatar
  • Doha, Qatar, 2713
    • Recruiting
    • Suhail Doi
    • Contact: Suhail Doi; Phone Number: 0097444037854; Email: sdoi@qu.edu.qa
    • Principal Investigator: Yaman Khamis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult Patients diagnosed with Acute Pancreatitis (AP)

Description

Inclusion Criteria:

• RCTs and observational studies that compared NS vs LR in AP patients.
• Studies reviewed must report data as effect estimates or provide raw data sufficient to calculate effect estimates.

Exclusion Criteria:

• Studies involving animal studies, pediatric patient populations, and cell lines will be excluded.

All studies will be reviewed in full form by each author to determine eligibility. In case of disagreement, determination of inclusion will be reached via consensus.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Lactated Ringer's (LR) solution
Normal Saline (NS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic inflammatory response syndrome (SIRS)	SIRS is defined as two out of the following four criteria: a) Temperature<36˚C (96.8˚F) or >38˚C (100.4˚F) b) Heart rate>90/min c) Respiratory rate>20/min d) WBC(<4000/mm3) (>12,000/mm3) or 10% bands.	at 24 hours

Collaborators and Investigators

• Sponsor: Qatar University
• Investigators: Principal Investigator: Suhail Doi, Qatar University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: November 13, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 28, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: 1983542-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No