Pancreatitis, AcuteNCT03642769
Lactated Ringer's Versus Normal Saline for Acute Pancreatitis
A study testing Fluid administration in people with Pancreatitis, Acute, run by University of Southern California at 1 site in United States.
Trial summary
Acute pancreatitis is a common problem in the United States necessitating 275,000 hospital admissions per year, with resultant healthcare costs of approximately 2.5 billion USD annually. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatitis, Acute
- What is being tested?
- Fluid administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2018to 16 Aug 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presentation with acute pancreatitis as defined by two of three criterion; amylase or lipase > 3x the upper limit of normal, classical abdominal pain, or imaging suggestive of pancreatitis. Such radiographic findings include swelling, edema, or heterogeneity of the gland or peripancreatic fluid or stranding.
Who cannot join
- Patients with severe pancreatitis as defined by the Revised Atlanta Classification will be excluded. Severe pancreatitis is defined by the Revised Atlanta Classification as those with a Modified Marshall score of >2 for their cardiovascular renal, or respiratory system will be excluded (Figure 2).13 Practically this includes patients with systolic blood pressure <90, serum creatinine >1.9, and PaO2/FiO2 <300 (Figure 3). Since blood gases are unlikely to be drawn on those with mild pancreatitis we will exclude patients with an oxygen saturation <92% on room air and certainly any patients which require intubation for respiratory failure due to pancreatitis.
- Patients who cannot tolerate increased doses of fluids for other reasons will also be excluded. This consists of those with cardiac insufficiency (CI, >NYHA Class II heart failure), pulmonary edema, dialysis requirement, or severe liver dysfunction (albumin < 3mg/dL, known cirrhosis).
- Pregnant women will also be excluded as they are prone to retain sodium and water, which puts them at increased risk of pulmonary congestion, ascites or peripheral edema.
- Patients who are incarcerated, younger than eighteen, or unable to give informed consent will be excluded.
- Individuals who present with clinical signs of edema or anasacra, including pulmonary congestion, peripheral swelling, and ascites, will also be ineligible for the study.
- Administration of fluids prior to the enrollment in the study will not be an exclusion criterion as this reflects actual clinical practice (hydration during evaluation period) however all fluids given prior to the study will be meticulously recorded.
Trial locations and contacts
1 site in 1 country.
United States1 site
LAC+USC Medical Center
Los Angeles, California, 90033
About this study
Official title: Lactated Ringer's Versus Normal Saline in the Management of Acute Pancreatitis
Acute pancreatitis is a common problem in the United States necessitating 275,000 hospital admissions per year, with resultant healthcare costs of approximately 2.5 billion USD annually. As numerous trials have failed to show a benefit to specific pharmacologic therapies in acute pancreatitis, the mainstay of treatment has been both supportive care and early, aggressive fluid resuscitation. Small randomized studies have shown conflicting results with regards to the influence of resuscitation fluid on outcomes in acute pancreatitis, necessitating a large randomized trial to clarify if fluid choice matters or not in the treatment of acute pancreatitis.
The objective of this study is to assess the comparative efficacy of normal saline versus lactated ringer's solution in the management of acute pancreatitis.
Read more
Patients presenting to the Los Angeles County Hospital with acute pancreatitis will be randomized to fluid resuscitation with NS or LR with volumes of fluid administered according to a pre-determined algorithm that will be the same for both treatment arms.
The primary outcome of the study will be the change in SIRS prevalence from enrollment to 24 hours. Secondary outcomes will include the change in SIRS prevalence from enrollment to 48 hours and 72 hours, development of moderately severe or severe pancreatitis, change in PASS score, ICU admission, length of hospitalization, persistent pain or disability after discharge, and time of advancement to oral diet and discharge.
Read the detailed description
Background: Acute pancreatitis is a common problem in the United States necessitating 275,000 hospital admissions per year, with resultant healthcare costs of approximately 2.5 billion USD annually. As numerous trials have failed to show a benefit to specific pharmacologic therapies in acute pancreatitis, the mainstay of treatment has been both supportive care and early, aggressive fluid resuscitation. Small randomized studies have shown conflicting results with regards to the influence of resuscitation fluid on outcomes in acute pancreatitis, necessitating a large randomized trial to clarify if fluid choice matters or not in the treatment of acute pancreatitis.
Objective: To assess the comparative efficacy of normal saline versus lactated ringer's solution in the management of acute pancreatitis.
Study Design: Patients presenting to the Los Angeles County Hospital with acute pancreatitis are the focus population of this study. Patients will be randomized to fluid resuscitation with NS or LR within 8 hours of diagnosis of pancreatitis. The inclusion and exclusion criterion will be assessed (see below). Randomization will be performed using a random sequence algorithm with concealed allocation. The patients will be blinded to allocation by covering the bag with an opaque covering. A study physician determining the outcomes will also be blinded. Following randomization, the volumes of fluid administered for the resuscitation will be determined by a pre-determined algorithm that will be the same for both treatment arms. The hydration algorithm is as follows: all patients will receive a bolus of the treatment fluid at a rate of 5 mL/kg/hour to be administered over the first two hours (total 10 mL/kg) with an assessment for volume overload at 1 hour. They will then will receive maintenance fluids at a rate of 3 mL/kg/hour. After 12 hours participants will have blood urea nitrogen (BUN) assessed, which is part of the standard clinical procedure. Those who do not have a fall in this parameter or who develop SIRS by this 12 hour checkpoint will receive a second 5 mL/kg/hour bolus over two hours (as above) of their designated treatment fluid followed by further treatment fluid at a rate of 3 mL/kg/hour. Those who do have a fall in BUN will receive further treatment fluid at a rate of 3 mL/kg/hour for 12 additional hours. Patients' volume status will be assessed in the following manner: study physicians will perform a targeted physical exam which will include assessment of JVD, lung auscultation, and monitoring for edema Q12 hours for the first 24 hours, then daily for the remainder of the hospital admission. In elderly patients and those with co-morbidities, the targeted physical exam will be performed Q12 hours for the entire hospital admission. Vitals will also be obtained Q6-8 hours. If they develop signs of fluid overload including pitting edema, ascites, anasacra, pulmonary edema, or dyspnea, or signs of renal failure including oliguria, anuria, or hypotension, they will have their fluid rate managed at the discretion of their treating physicians. However, it will be requested that if further fluid is given that it be the assigned type (LR versus NS). At 24 hours patients will be assessed for SIRS development (see outcomes). Beyond this point fluid rate will be per the primary team though it still be encouraged that the assigned type of fluid (LR versus NS) is used for additional resuscitation with the rate and volume beyond this point at the discretion of the treating physician. However, if the treating physicians have a strong preference to change to a different fluid type for clinical reasons this will be recorded (for post hoc analysis) and the patient included in the intention to treat analysis.
- Conditions
- Pancreatitis, Acute
- Being tested
- Fluid administration
- Keywords
- Pancreatitis, Fluids, SIRS, Management, Lactated Ringer, Normal Saline
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid administrationOther
Also called Fluid
Fluid administration of bolus and maintenance fluids
| Study group | Role | What they receive |
|---|---|---|
| Lactated Ringer | Active comparator | Patients will receive fluid administration of Lactated Ringer's solution at a pre-determined volume algorithm that is the same for both arms Receives: Other: Fluid administration |
| Normal Saline | Experimental | Patients will receive fluid administration of Normal Saline solution at a pre-determined volume algorithm that is the same for both arms Receives: Other: Fluid administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
SIRS at 24 hours
Change in SIRS prevalence from enrollment to 24 hours
Measured: 24 hours
Secondary outcomes (12)
SIRS at 48 hours
Proportion of patients with change in SIRS from enrollment to 48 hours
Measured: 48 hours
SIRS at 72 hours
Change in SIRS prevalence from enrollment to 72 hours
Measured: 72 hours
Moderately severe acute pancreatitis
Development of moderately severe acute pancreatitis
Measured: 48 hours
Severe acute pancreatitis
Development of severe acute pancreatitis
Measured: >48 hours
PASS score
Change in PASS score from enrollment to 24 hours
Measured: 24 hours
PASS score
Change in PASS score from enrollment to 48 hours
Measured: 48 hours
PASS score
Change in PASS score from enrollment to 72 hours
Measured: 72 hours
ICU admission
ICU admission and ICU intervention including intubation, respiratory distress with out intubation defined as RR>20 AND O2 Sat<90% on room air, death, development of extrapancreatic fluid collection (EPFS)
Measured: >72 hours
Length of hospitalization
Length of hospitalization
Measured: >72 hours
Pain after discharge based on a 0-10 intensity scale (10 most severe, 0 none)
Report of persistent pain or disability after discharge based on telephone follow-up based on a 0-10 intensity scale (10 most severe, 0 none)
Measured: 2 weeks
Advance diet
Time to advancement of oral diet
Measured: >48 hours
Time to work
Time to work after hospitalization based on post-discharge telephone follow-up
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start18 Sep 2018
- Primary completion16 Aug 2021
- Study completion16 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Pancreatitis, AcuteStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Buxbaum, University of Southern California
- Investigators
- James Buxbaum, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642769
- Sponsor's protocol ID
- APP-17-06494
- Status last verified
- Dec 2021
- First submitted
- 12 Feb 2018
- Last updated
- 8 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.
PubMed 23896955Singh VK, Gardner TB, Papachristou GI, Rey-Riveiro M, Faghih M, Koutroumpakis E, Afghani E, Acevedo-Piedra NG, Seth N, Sinha A, Quesada-Vazquez N, Moya-Hoyo N, Sanchez-Marin C, Martinez J, Lluis F, Whitcomb DC, Zapater P, de-Madaria E. An international multicenter study of early intravenous fluid administration and outcome in acute pancreatitis. United European Gastroenterol J. 2017 Jun;5(4):491-498. doi: 10.1177/2050640616671077. Epub 2016 Sep 20.
PubMed 28588879Forsmark CE, Vege SS, Wilcox CM. Acute Pancreatitis. N Engl J Med. 2016 Nov 17;375(20):1972-1981. doi: 10.1056/NEJMra1505202.
PubMed 27959604Buxbaum JL, Quezada M, Da B, Jani N, Lane C, Mwengela D, Kelly T, Jhun P, Dhanireddy K, Laine L. Early Aggressive Hydration Hastens Clinical Improvement in Mild Acute Pancreatitis. Am J Gastroenterol. 2017 May;112(5):797-803. doi: 10.1038/ajg.2017.40. Epub 2017 Mar 7.
PubMed 28266591Cuthbertson CM, Christophi C. Disturbances of the microcirculation in acute pancreatitis. Br J Surg. 2006 May;93(5):518-30. doi: 10.1002/bjs.5316.
PubMed 16607683Raghunathan K, Shaw A, Nathanson B, Sturmer T, Brookhart A, Stefan MS, Setoguchi S, Beadles C, Lindenauer PK. Association between the choice of IV crystalloid and in-hospital mortality among critically ill adults with sepsis*. Crit Care Med. 2014 Jul;42(7):1585-91. doi: 10.1097/CCM.0000000000000305.
PubMed 24674927Rochwerg B, Alhazzani W, Sindi A, Heels-Ansdell D, Thabane L, Fox-Robichaud A, Mbuagbaw L, Szczeklik W, Alshamsi F, Altayyar S, Ip WC, Li G, Wang M, Wludarczyk A, Zhou Q, Guyatt GH, Cook DJ, Jaeschke R, Annane D; Fluids in Sepsis and Septic Shock Group. Fluid resuscitation in sepsis: a systematic review and network meta-analysis. Ann Intern Med. 2014 Sep 2;161(5):347-55. doi: 10.7326/M14-0178.
PubMed 25047428Correa TD, Cavalcanti AB, Assuncao MS. Balanced crystalloids for septic shock resuscitation. Rev Bras Ter Intensiva. 2016 Oct-Dec;28(4):463-471. doi: 10.5935/0103-507X.20160079.
PubMed 28099643Wu BU, Hwang JQ, Gardner TH, Repas K, Delee R, Yu S, Smith B, Banks PA, Conwell DL. Lactated Ringer's solution reduces systemic inflammation compared with saline in patients with acute pancreatitis. Clin Gastroenterol Hepatol. 2011 Aug;9(8):710-717.e1. doi: 10.1016/j.cgh.2011.04.026. Epub 2011 May 12.
PubMed 21645639Lipinski M, Rydzewska-Rosolowska A, Rydzewski A, Rydzewska G. Fluid resuscitation in acute pancreatitis: Normal saline or lactated Ringer's solution? World J Gastroenterol. 2015 Aug 21;21(31):9367-72. doi: 10.3748/wjg.v21.i31.9367.
PubMed 26309362de-Madaria E, Soler-Sala G, Lopez-Font I, Zapater P, Martinez J, Gomez-Escolar L, Sanchez-Fortun C, Sempere L, Perez-Lopez J, Lluis F, Perez-Mateo M. Update of the Atlanta Classification of severity of acute pancreatitis: should a moderate category be included? Pancreatology. 2010;10(5):613-9. doi: 10.1159/000308795. Epub 2010 Oct 30.
PubMed 21042037Balthazar EJ. Acute pancreatitis: assessment of severity with clinical and CT evaluation. Radiology. 2002 Jun;223(3):603-13. doi: 10.1148/radiol.2233010680.
PubMed 12034923Warndorf MG, Kurtzman JT, Bartel MJ, Cox M, Mackenzie T, Robinson S, Burchard PR, Gordon SR, Gardner TB. Early fluid resuscitation reduces morbidity among patients with acute pancreatitis. Clin Gastroenterol Hepatol. 2011 Aug;9(8):705-9. doi: 10.1016/j.cgh.2011.03.032. Epub 2011 Apr 8.
PubMed 21554987Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.
PubMed 2070995Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
PubMed 23100216
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactated Ringer's Versus Normal Saline in the Management of Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT03642769
- Acronym / sponsor ID
- APP-17-06494
- Conditions
- Pancreatitis, Acute
- Keywords
- Pancreatitis, Fluids, SIRS, Management, Lactated Ringer, Normal Saline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 22 Aug 2018 (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.
Acute pancreatitis is a common problem in the United States necessitating 275,000 hospital admissions per year, with resultant healthcare costs of approximately 2.5 billion USD annually. As numerous trials have failed to show a benefit to specific pharmacologic therapies in acute pancreatitis, the mainstay of treatment has been both supportive care and early, aggressive fluid resuscitation. Small randomized studies have shown conflicting results with regards to the influence of resuscitation fluid on outcomes in acute pancreatitis, necessitating a large randomized trial to clarify if fluid choice matters or not in the treatment of acute pancreatitis.
The objective of this study is to assess the comparative efficacy of normal saline versus lactated ringer's solution in the management of acute pancreatitis.
Patients presenting to the Los Angeles County Hospital with acute pancreatitis will be randomized to fluid resuscitation with NS or LR with volumes of fluid administered according to a pre-determined algorithm that will be the same for both treatment arms.
The primary outcome of the study will be the change in SIRS prevalence from enrollment to 24 hours. Secondary outcomes will include the change in SIRS prevalence from enrollment to 48 hours and 72 hours, development of moderately severe or severe pancreatitis, change in PASS score, ICU admission, length of hospitalization, persistent pain or disability after discharge, and time of advancement to oral diet and discharge.
Detailed description
Background: Acute pancreatitis is a common problem in the United States necessitating 275,000 hospital admissions per year, with resultant healthcare costs of approximately 2.5 billion USD annually. As numerous trials have failed to show a benefit to specific pharmacologic therapies in acute pancreatitis, the mainstay of treatment has been both supportive care and early, aggressive fluid resuscitation. Small randomized studies have shown conflicting results with regards to the influence of resuscitation fluid on outcomes in acute pancreatitis, necessitating a large randomized trial to clarify if fluid choice matters or not in the treatment of acute pancreatitis.
Objective: To assess the comparative efficacy of normal saline versus lactated ringer's solution in the management of acute pancreatitis.
Study Design: Patients presenting to the Los Angeles County Hospital with acute pancreatitis are the focus population of this study. Patients will be randomized to fluid resuscitation with NS or LR within 8 hours of diagnosis of pancreatitis. The inclusion and exclusion criterion will be assessed (see below). Randomization will be performed using a random sequence algorithm with concealed allocation. The patients will be blinded to allocation by covering the bag with an opaque covering. A study physician determining the outcomes will also be blinded. Following randomization, the volumes of fluid administered for the resuscitation will be determined by a pre-determined algorithm that will be the same for both treatment arms. The hydration algorithm is as follows: all patients will receive a bolus of the treatment fluid at a rate of 5 mL/kg/hour to be administered over the first two hours (total 10 mL/kg) with an assessment for volume overload at 1 hour. They will then will receive maintenance fluids at a rate of 3 mL/kg/hour. After 12 hours participants will have blood urea nitrogen (BUN) assessed, which is part of the standard clinical procedure. Those who do not have a fall in this parameter or who develop SIRS by this 12 hour checkpoint will receive a second 5 mL/kg/hour bolus over two hours (as above) of their designated treatment fluid followed by further treatment fluid at a rate of 3 mL/kg/hour. Those who do have a fall in BUN will receive further treatment fluid at a rate of 3 mL/kg/hour for 12 additional hours. Patients' volume status will be assessed in the following manner: study physicians will perform a targeted physical exam which will include assessment of JVD, lung auscultation, and monitoring for edema Q12 hours for the first 24 hours, then daily for the remainder of the hospital admission. In elderly patients and those with co-morbidities, the targeted physical exam will be performed Q12 hours for the entire hospital admission. Vitals will also be obtained Q6-8 hours. If they develop signs of fluid overload including pitting edema, ascites, anasacra, pulmonary edema, or dyspnea, or signs of renal failure including oliguria, anuria, or hypotension, they will have their fluid rate managed at the discretion of their treating physicians. However, it will be requested that if further fluid is given that it be the assigned type (LR versus NS). At 24 hours patients will be assessed for SIRS development (see outcomes). Beyond this point fluid rate will be per the primary team though it still be encouraged that the assigned type of fluid (LR versus NS) is used for additional resuscitation with the rate and volume beyond this point at the discretion of the treating physician. However, if the treating physicians have a strong preference to change to a different fluid type for clinical reasons this will be recorded (for post hoc analysis) and the patient included in the intention to treat analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactated Ringer | Active comparator | Other: Fluid administrationPatients will receive fluid administration of Lactated Ringer's solution at a pre-determined volume algorithm that is the same for both arms |
| Normal Saline | Experimental | Other: Fluid administrationPatients will receive fluid administration of Normal Saline solution at a pre-determined volume algorithm that is the same for both arms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presentation with acute pancreatitis as defined by two of three criterion; amylase or lipase > 3x the upper limit of normal, classical abdominal pain, or imaging suggestive of pancreatitis. Such radiographic findings include swelling, edema, or heterogeneity of the gland or peripancreatic fluid or stranding.
Key exclusion criteria (6 listed)
- Patients with severe pancreatitis as defined by the Revised Atlanta Classification will be excluded. Severe pancreatitis is defined by the Revised Atlanta Classification as those with a Modified Marshall score of >2 for their cardiovascular renal, or respiratory system will be excluded (Figure 2).13 Practically this includes patients with systolic blood pressure <90, serum creatinine >1.9, and PaO2/FiO2 <300 (Figure 3). Since blood gases are unlikely to be drawn on those with mild pancreatitis we will exclude patients with an oxygen saturation <92% on room air and certainly any patients which require intubation for respiratory failure due to pancreatitis.
- Patients who cannot tolerate increased doses of fluids for other reasons will also be excluded. This consists of those with cardiac insufficiency (CI, >NYHA Class II heart failure), pulmonary edema, dialysis requirement, or severe liver dysfunction (albumin < 3mg/dL, known cirrhosis).
- Pregnant women will also be excluded as they are prone to retain sodium and water, which puts them at increased risk of pulmonary congestion, ascites or peripheral edema.
- Patients who are incarcerated, younger than eighteen, or unable to give informed consent will be excluded.
- Individuals who present with clinical signs of edema or anasacra, including pulmonary congestion, peripheral swelling, and ascites, will also be ineligible for the study.
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 |
|---|---|---|
| Fluid administrationAlso: FluidFluid administration of bolus and maintenance fluids | Other | Lactated Ringer, Normal Saline |
Primary outcome
SIRS at 24 hours
Time frame: 24 hours
Change in SIRS prevalence from enrollment to 24 hours
12 secondary outcomes
SIRS at 48 hours
Time frame: 48 hours
SIRS at 72 hours
Time frame: 72 hours
Moderately severe acute pancreatitis
Time frame: 48 hours
Severe acute pancreatitis
Time frame: >48 hours
PASS score
Time frame: 24 hours
PASS score
Time frame: 48 hours
PASS score
Time frame: 72 hours
ICU admission
Time frame: >72 hours
Length of hospitalization
Time frame: >72 hours
Pain after discharge based on a 0-10 intensity scale (10 most severe, 0 none)
Time frame: 2 weeks
Advance diet
Time frame: >48 hours
Time to work
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Background: PubMed 23896955Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.
- Background: PubMed 28588879Singh VK, Gardner TB, Papachristou GI, Rey-Riveiro M, Faghih M, Koutroumpakis E, Afghani E, Acevedo-Piedra NG, Seth N, Sinha A, Quesada-Vazquez N, Moya-Hoyo N, Sanchez-Marin C, Martinez J, Lluis F, Whitcomb DC, Zapater P, de-Madaria E. An international multicenter study of early intravenous fluid administration and outcome in acute pancreatitis. United European Gastroenterol J. 2017 Jun;5(4):491-498. doi: 10.1177/2050640616671077. Epub 2016 Sep 20.
- Background: PubMed 27959604Forsmark CE, Vege SS, Wilcox CM. Acute Pancreatitis. N Engl J Med. 2016 Nov 17;375(20):1972-1981. doi: 10.1056/NEJMra1505202.
- Background: PubMed 28266591Buxbaum JL, Quezada M, Da B, Jani N, Lane C, Mwengela D, Kelly T, Jhun P, Dhanireddy K, Laine L. Early Aggressive Hydration Hastens Clinical Improvement in Mild Acute Pancreatitis. Am J Gastroenterol. 2017 May;112(5):797-803. doi: 10.1038/ajg.2017.40. Epub 2017 Mar 7.
- Background: PubMed 16607683Cuthbertson CM, Christophi C. Disturbances of the microcirculation in acute pancreatitis. Br J Surg. 2006 May;93(5):518-30. doi: 10.1002/bjs.5316.
- Background: PubMed 24674927Raghunathan K, Shaw A, Nathanson B, Sturmer T, Brookhart A, Stefan MS, Setoguchi S, Beadles C, Lindenauer PK. Association between the choice of IV crystalloid and in-hospital mortality among critically ill adults with sepsis*. Crit Care Med. 2014 Jul;42(7):1585-91. doi: 10.1097/CCM.0000000000000305.
- Background: PubMed 25047428Rochwerg B, Alhazzani W, Sindi A, Heels-Ansdell D, Thabane L, Fox-Robichaud A, Mbuagbaw L, Szczeklik W, Alshamsi F, Altayyar S, Ip WC, Li G, Wang M, Wludarczyk A, Zhou Q, Guyatt GH, Cook DJ, Jaeschke R, Annane D; Fluids in Sepsis and Septic Shock Group. Fluid resuscitation in sepsis: a systematic review and network meta-analysis. Ann Intern Med. 2014 Sep 2;161(5):347-55. doi: 10.7326/M14-0178.
- Background: PubMed 28099643Correa TD, Cavalcanti AB, Assuncao MS. Balanced crystalloids for septic shock resuscitation. Rev Bras Ter Intensiva. 2016 Oct-Dec;28(4):463-471. doi: 10.5935/0103-507X.20160079.
- Background: PubMed 21645639Wu BU, Hwang JQ, Gardner TH, Repas K, Delee R, Yu S, Smith B, Banks PA, Conwell DL. Lactated Ringer's solution reduces systemic inflammation compared with saline in patients with acute pancreatitis. Clin Gastroenterol Hepatol. 2011 Aug;9(8):710-717.e1. doi: 10.1016/j.cgh.2011.04.026. Epub 2011 May 12.
- Background: PubMed 26309362Lipinski M, Rydzewska-Rosolowska A, Rydzewski A, Rydzewska G. Fluid resuscitation in acute pancreatitis: Normal saline or lactated Ringer's solution? World J Gastroenterol. 2015 Aug 21;21(31):9367-72. doi: 10.3748/wjg.v21.i31.9367.
- Background: PubMed 21042037de-Madaria E, Soler-Sala G, Lopez-Font I, Zapater P, Martinez J, Gomez-Escolar L, Sanchez-Fortun C, Sempere L, Perez-Lopez J, Lluis F, Perez-Mateo M. Update of the Atlanta Classification of severity of acute pancreatitis: should a moderate category be included? Pancreatology. 2010;10(5):613-9. doi: 10.1159/000308795. Epub 2010 Oct 30.
- Background: PubMed 12034923Balthazar EJ. Acute pancreatitis: assessment of severity with clinical and CT evaluation. Radiology. 2002 Jun;223(3):603-13. doi: 10.1148/radiol.2233010680.
- Individual participant dataSharing planned: Undecided
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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.
James Buxbaum, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid administration in people with Pancreatitis, Acute, run by University of Southern California at 1 site in United States.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 8 Dec 2021. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SIRS at 24 hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03642769, which also lists 17 linked publications.
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 8 Dec 2021.