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

NCT05638555 | Unknown

• 1 other identifier: 1983542-1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lactated Ringer's (LR) solution

Normal Saline (NS)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult Patients diagnosed with Acute Pancreatitis (AP)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Qatar University: lead

Study Sites (1)

Suhail Doi

Doha, 2713, Qatar

RECRUITING

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Suhail Doi

  Qatar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suhail Doi

CONTACT

0097444037854; sdoi@qu.edu.qa

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Group Leader

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: December 6, 2022
• Study Start: August 15, 2023
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

QA (1)