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

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05638555
• Other study ID #: 1983542-1
• Status: Recruiting
• Start date: August 15, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: October 2023
• Source: Qatar University
• Contact: Suhail Doi
• Phone: 0097444037854
• Email: sdoi[@]qu.edu.qa
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Locations

Country	Name	City	State
Qatar	Suhail Doi	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Qatar University

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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