Post-ERCP Acute PancreatitisNCT03215862
Lactated Ringer's Solution to Prevent Post-ERCP Pancreatitis
A study testing Lactated Ringer and Normal Saline 0.9% Infusion Solution Bag in people with Post-ERCP Acute Pancreatitis, run by University of South Florida.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Post-ERCP Acute Pancreatitis
- What is being tested?
- Lactated Ringer and Normal Saline 0.9% Infusion Solution Bag
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2017to 1 Aug 2018
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Suspicion of Oddi dysfunction
- Personal history of post-ERCP pancreatitis
- More than 8 cannulation attempts
- Precut sphincterotomy
- Endoscopic papillary balloon dilation of an intact sphincter
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- Endoscopic pancreatic duct sphincterotomy
- Ampullectomy
- Total bilirubin < 1.0
- Or possession of two or more of the following minor criteria:
- Female sex
- Age under 50 years
- Personal history of recurrent acute pancreatitis
- Pancreatic duct injection leading to "acinarization" or over 3 pancreatic duct injections
- Pancreatic duct cytology acquisition
Who cannot join
- Patients aged less than 18
- Inability to provide informed consent
- Pregnancy
- Active acute pancreatitis
- Any contraindication to aggressive IVF hydration: evidence of clinical volume overload (peripheral or pulmonary edema), respiratory compromise (oxygen saturation < 90% on room air), chronic kidney disease (creatinine clearance < 40 mL/min), systolic congestive heart failure (ejection fraction < 45%), cirrhosis, and severe electrolyte disturbance with sodium <130 mEq/L or >150 mEq/L
- If patient does not undergo a planned high-risk intervention
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- If patient does not possess complete criteria which places them at high risk for post-ERCP pancreatitis
- Patients with cholangitis
- Patients with chronic and/or active pancreatitis
- Patients with a true NSAID allergy
- Patients greater than or equal to 75 years old
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of the Use of Lactated Ringer's Solution During ERCP on Rate of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
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.
- Conditions
- Post-ERCP Acute Pancreatitis
- Being tested
- Lactated Ringer, Normal Saline 0.9% Infusion Solution Bag
- Keywords
- Post-ERCP Acute Pancreatitis, Normal Saline, Lactated Ringer's
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactated RingerDrug
This is a Lactated Ringer's solution infusion before, during, and after the ERCP procedure.
Normal Saline 0.9% Infusion Solution BagDrug
This is a Normal Saline solution infusion before, during, and after the ERCP procedure.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Drug: Normal Saline 0.9% Infusion Solution Bag |
| Experimental | Experimental | Not described Receives: Drug: Lactated Ringer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-ercp pancreatitis
The occurrence of pancreatitis as a complication of ERCP procedure, assessed 24 hours after the procedure is completed.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start1 Aug 2017 (estimated)
- Primary completion1 Aug 2018 (estimated)
- Study completion1 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-ERCP 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pushpak Taunk, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215862
- Sponsor's protocol ID
- Pro00029546
- Status last verified
- Jul 2017
- First submitted
- 10 Jul 2017
- Last updated
- 12 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Use of Lactated Ringer's Solution During ERCP on Rate of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
- ClinicalTrials.gov ID
- NCT03215862
- Acronym / sponsor ID
- Pro00029546
- Conditions
- Post-ERCP Acute Pancreatitis
- Keywords
- Post-ERCP Acute Pancreatitis, Normal Saline, Lactated Ringer's
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 12 Jul 2017 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Normal Saline 0.9% Infusion Solution Bag |
| Experimental | Experimental | Drug: Lactated Ringer |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- Suspicion of Oddi dysfunction
- Personal history of post-ERCP pancreatitis
- More than 8 cannulation attempts
- Precut sphincterotomy
Key exclusion criteria (11 listed)
- Patients aged less than 18
- Inability to provide informed consent
- Pregnancy
- Active acute pancreatitis
- Any contraindication to aggressive IVF hydration: evidence of clinical volume overload (peripheral or pulmonary edema), respiratory compromise (oxygen saturation < 90% on room air), chronic kidney disease (creatinine clearance < 40 mL/min), systolic congestive heart failure (ejection fraction < 45%), cirrhosis, and severe electrolyte disturbance with sodium <130 mEq/L or >150 mEq/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactated RingerThis is a Lactated Ringer's solution infusion before, during, and after the ERCP procedure. | Drug | Experimental |
| Normal Saline 0.9% Infusion Solution BagThis is a Normal Saline solution infusion before, during, and after the ERCP procedure. | Drug | Control |
Primary outcome
Post-ercp pancreatitis
Time frame: 24 hours
The occurrence of pancreatitis as a complication of ERCP procedure, assessed 24 hours after the procedure is completed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Individual participant dataSharing planned: No
Related trials for Post-ERCP Acute Pancreatitis
Not yet recruiting
Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
Post ERCP Pancreatitis, Acute Pancreatitis (AP)
Not yet recruiting
Prophylactic Sphincterotomy in Acute Biliary Pancreatitis Patients Unfit for Surgery
Acute Biliary Pancreatitis
Recruiting
Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis
Pancreatitis, Acute
RecruitingObservational study
An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis
Post-ERCP Acute Pancreatitis
Not yet recruitingPhase 4
Indomethacin for Biliary ERCP Patients
Pancreatitis Biliary, Pancreatitis Acute Biliary
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.
Pushpak Taunk, MD principal investigator
University of South Florida
Questions about this trial
What is this clinical trial studying?
A study testing Lactated Ringer and Normal Saline 0.9% Infusion Solution Bag in people with Post-ERCP Acute Pancreatitis, run by University of South Florida.
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 15 inclusion and 11 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: opening soon, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Primary Investigator (8139743980, ptaunk@health.usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-ercp pancreatitis (time frame: 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 12 Jul 2017.