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

Sponsor
Qatar University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05638555
Collaborator
(none)
500
Enrollment
1
Location
8.5
Anticipated Duration (Months)
58.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Lactated Ringers vs Normal Saline in Patients With Acute Pancreatitis: A Bias-Adjusted Meta-analysis
    Anticipated Study Start Date :
    Dec 15, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Lactated Ringer's (LR) solution
    Normal Saline (NS)

    Outcome Measures

    Primary Outcome Measures

    1. Systemic inflammatory response syndrome (SIRS) [at 24 hours]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Suhail Doi Doha Qatar 2713

    Sponsors and Collaborators

    • Qatar University

    Investigators

    • Principal Investigator: Suhail Doi, Qatar University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yaman Khamis, Group Leader, Qatar University
    ClinicalTrials.gov Identifier:
    NCT05638555
    Other Study ID Numbers:
    • 1983542-1
    First Posted:
    Dec 6, 2022
    Last Update Posted:
    Dec 6, 2022
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pancreatitis

    Study Results

    No Results Posted as of Dec 6, 2022