Acute PancreatitisNCT05638555
Lactated Ringers vs Normal Saline in Patients With Acute Pancreatitis: A Bias-Adjusted Meta-analysis
An observational study of Acute Pancreatitis, run by Qatar University at 1 site in Qatar.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Pancreatitis
- How many people
- 500 participants
- Where
- 1 siteQatar
- Study dates
- 15 Aug 2023to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult Patients diagnosed with Acute Pancreatitis (AP)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
Suhail Doi
Doha, 2713
Suhail Doi, 0097444037854, sdoi@qu.edu.qa
Yaman Khamis
About this study
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
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lactated Ringer's (LR) solution | Not described | |
| Normal Saline (NS) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic inflammatory response syndrome (SIRS)
SIRS is defined as two out of the following four criteria:
- 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.
Measured: at 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start15 Aug 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qatar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaman Khamis, Qatar University
- Investigators
- Suhail Doi, Principal investigator, Qatar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638555
- Sponsor's protocol ID
- 1983542-1
- Status last verified
- Oct 2023
- First submitted
- 13 Nov 2022
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactated Ringers vs Normal Saline in Patients With Acute Pancreatitis: A Bias-Adjusted Meta-analysis
- ClinicalTrials.gov ID
- NCT05638555
- Acronym / sponsor ID
- 1983542-1
- Conditions
- Acute Pancreatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Qatar UniversityUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactated Ringer's (LR) solution | – | – |
| Normal Saline (NS) | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult Patients diagnosed with Acute Pancreatitis (AP)
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Systemic inflammatory response syndrome (SIRS)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suhail Doi principal investigator
Qatar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis, run by Qatar University at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suhail Doi (0097444037854, sdoi@qu.edu.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic inflammatory response syndrome (SIRS) (time frame: at 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.