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RecruitingNCT05638555Updated Oct 31, 2023

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

An observational study in Acute Pancreatitis, sponsored by Qatar University. Recruiting at 1 site in Qatar. Per ClinicalTrials.gov, last updated 2023-10-31.

Sponsored by Qatar University · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 2 months later.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
500
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Pancreatitis

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03

In context

Pancreatitis

557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.

This study's planned enrollment of 500 is above the median of 200 across 192 observational studies indexed under Pancreatitis.

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Lead sponsor

Qatar University is the lead sponsor of 9 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult Patients diagnosed with Acute Pancreatitis (AP)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Lactated Ringer's (LR) solution
  • Normal Saline (NS)
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What researchers measure

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.

    Time frame: at 24 hours

07

Study locations

1 of 1 sites recruiting
  • Suhail Doi
    Doha, 2713, Qatar
    Recruiting
    • Suhail Doi · Contactsdoi@qu.edu.qa · 0097444037854
    • Yaman Khamis · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05638555
Lead sponsor
Qatar University
Responsible party
Yaman Khamis (Group Leader, Qatar University) — Principal investigator
First posted
Dec 6, 2022
Start date
Aug 15, 2023
Primary completion
Apr 1, 2024 (estimated)
Completion
Jun 1, 2024 (estimated)
Last update
Oct 31, 2023

Study contacts

Suhail Doi
Contact
sdoi@qu.edu.qa
0097444037854
Suhail Doi
principal investigator · Qatar University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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