Lactated Ringer
DrugThis is a Lactated Ringer's solution infusion before, during, and after the ERCP procedure.
NCT Number: NCT03215862
This is a randomized, double-blinded, controlled trial. This study is a head to head comparison of normal saline (NS) infusion versus Lactated Ringer's (LR) infusion in patients, with the primary outcome of post-ERCP pancreatitis occurrence. Patients will be randomized to either the NS infusion group or the LR infusion group. IVF will be started pre-procedurally and will be continued throughout the procedure. A IVF bolus will be given at the end of the procedure and then continued as a continuous infusion. Our null hypothesis is that there will be no significant difference in the rate of occurrence of post-ERCP pancreatitis between the infusion of LR and NS solutions. Our alternative hypothesis is that patients receiving LR solution infusion will experience a decreased rate of post-ERCP pancreatitis compared to patients receiving NS solution infusion.
Trial opening soon.
Get Notified18 year–74 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
i. Possession of one of the following criteria which places the patient at high risk for post-ERCP pancreatitis and/or if patient is to undergo a planned endoscopic intervention deemed at high risk:
ii. Or possession of two or more of the following minor criteria:
Exclusion criteria
This is a Lactated Ringer's solution infusion before, during, and after the ERCP procedure.
This is a Normal Saline solution infusion before, during, and after the ERCP procedure.
Time frame: 24 hours
The occurrence of pancreatitis as a complication of ERCP procedure, assessed 24 hours after the procedure is completed.
Contact information is provided by the study sponsor or research team.
Primary Investigator
CONTACT
Researcher
CONTACT
University of South Florida
Other
The Effect of the Use of Lactated Ringer's Solution During ERCP on Rate of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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