Acute PancreatitisPhase 4WATERLANDNCT05781243
Normal Saline Versus Lactated Ringer's Solution for Acute Pancreatitis Resuscitation
A Phase 4 study testing Lactated Ringer Solution and Normal saline in people with Acute Pancreatitis, run by Enrique de-Madaria at 1 site in Spain.
Trial summary
Background: Some evidence suggests that fluid resuscitation with lactated Ringer's solution (LR) may have an anti-inflammatory effect on acute pancreatitis (AP) when compared to normal saline (NS), and may be associated with a decrease in severity, but existing single center randomized controlled trials showed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Lactated Ringer Solution and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 812 participants
- Where
- 1 siteSpain
- Study dates
- 19 Jun 2023to 30 Aug 2024
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is 18 years or older
- Diagnosis of acute pancreatitis according to the revision of the Atlanta classification (Banks et al, Gut 2013), which requires at least two of the following three criteria: A) typical abdominal pain, B) increase in serum amylase or lipase levels higher than three times the upper limit of normality, and C) signs of acute pancreatitis in imaging
- Signature of informed consent
Who cannot join
- New York Heart Association class II heart failure (slight limitation of physical activity; fatigue, palpitations, or dyspnea with ordinal physical activity) or worse, or ejection fraction <50% in the last echocardiography
- Decompensated cirrhosis (Child's class B or C)
- Hyper or hyponatremia (<135 or >145 mEq/L)
- Hyperkalemia (>5 mEq/L)
- Hypercalcemia (albumin or protein-corrected calcium >10.5 mg/dL or 2.62 mmol/L)
- Criteria for moderately severe or severe acute pancreatitis (revision of the Atlanta classification, Banks et al, Gut 2013) at recruitment: any of the following: A) presence of creatinine ≥1.9 mg/dL or ≥170 mmol/l, B) PaO2/FiO2≤300, C) systolic blood pressure <90 mmHg despite initial fluid resuscitation, D) presence of local complications (acute peripancreatic fluid collections, acute necrotic collection, pseudocyst, walled-off necrosis, gastric outlet dysfunction, splenic or portal vein thrombosis, or colonic necrosis), E) exacerbation of previous comorbidity such as coronary artery disease or chronic lung disease, precipitated by the acute pancreatitis
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- Signs of volume overload or heart failure at recruitment (peripheral edema, pulmonary rales, or increased jugular ingurgitation at 45º)
- Time from pain onset to arrival to emergency room >24 h
- Time from confirmation of pancreatitis to randomization >8 h
- Chronic pancreatitis defined by a Wirsung duct ≥4mm and/or pancreatic calcifications
- More than 1 previous episode of acute pancreatitis (only 2 episodes of acute pancreatitis are allowed, one of them the present episode)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Normal Saline Versus Lactated Ringer's Solution for Acute Pancreatitis Resuscitation, an Open-label Multicenter Randomized Controlled Trial: the WATERLAND Trial
Background: Some evidence suggests that fluid resuscitation with lactated Ringer's solution (LR) may have an anti-inflammatory effect on acute pancreatitis (AP) when compared to normal saline (NS), and may be associated with a decrease in severity, but existing single center randomized controlled trials showed conflicting results. The WATERLAND trial aims to investigate the efficacy and safety of fluid resuscitation using LR compared to NS in patients with AP.
Methods: The WATERLAND trial is an international multicenter, open-label, parallel-group, randomized, controlled, superiority trial. Patients will be randomly assigned in a 1:1 ratio to receive LR versus NS-based fluid resuscitation for at least 48 hours. The primary outcome will be moderately severe or severe AP, according to the revision of the Atlanta classification. The secondary objectives of the WATERLAND trial are to determine the effect of LR versus NS fluid resuscitation on several efficacy and safety outcomes in patients with AP.
Read more
A total sample of 720 patients, 360 in the LR group and 360 in the NS group, will achieve 90% power to detect a difference between the group proportions of 10%, assuming that the frequency of moderately severe or severe AP in the LR group will be 17%. A loss to follow-up of 10% of patients is expected, so the total sample size will be 396 patients in each treatment arm (792 patients overall). The test statistic used is the two-sided Z test with pooled variance set at a 0.05 significance level.
Discussion: The WATERLAND study aims to improve the early management of AP. Fluid resuscitation is an inexpensive treatment available in any hospital center worldwide. If a better evolution of pancreatitis is demonstrated in one of the treatment arms, it would have important repercussions in the management of this frequent disease.
Read the detailed description
The entire protocol is published in open-access format, including the Statistical Analysis plan, in the journal Trials: https://doi.org/10.1186/s13063-024-08539-2
- Conditions
- Acute Pancreatitis
- Being tested
- Lactated Ringer Solution, Normal saline
- Keywords
- Normal saline, Lactated Ringer solution, Acute pancreatitis, Fluid Therapy, Fluid resuscitation
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactated Ringer SolutionDrug
Patients in the LR (Lactated Ringer solution) treatment arm will receive fluid therapy based on lactated Ringer's solution for a minimum of 48 hours.
Normal salineDrug
Patients in the NS (Normal Saline) treatment arm will receive fluid therapy based on lactated Ringer's solution for a minimum of 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Lactated Ringer solution (LR) | Experimental | LR: Lactated Ringer solution. Patients in the LR treatment arm will receive fluid therapy based on lactated Ringer's solution for a minimum of 48 hours. Receives: Drug: Lactated Ringer Solution |
| Normal saline (NS) | Active comparator | NS: Normal Saline. Patients in the NS treatment arm will receive fluid therapy based on normal saline for a minimum of 48 hours. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with moderately severe or severe acute pancreatitis
Presence of local complications, exacerbation of previous comorbidity or organ failure, according to the definitions of these complications provided by the revised Atlanta Classification (https://doi.org/10.1136/gutjnl-2012-302779)
Measured: From date of randomization until 30 days after randomization
Secondary outcomes (28)
Number of participants with local complications
Presence of acute peripancreatic fluid collections, acute necrotic collection, pseudocyst, walled-off necrosis, gastric outlet dysfunction, splenic or portal vein thrombosis, and colonic necrosis according to the revised Atlanta Classification (https://doi.org/10.1136/gutjnl-2012-302779).
Measured: From date of randomization until 30 days after randomization
Number of participants with necrotizing pancreatitis
Presence of acute necrotic collections according to the revised Atlanta Classification (https://doi.org/10.1136/gutjnl-2012-302779).
Measured: From date of randomization until 30 days after randomization
Number of participants with infection of pancreatic collections or necrosis
Extraluminal gas in the pancreatic and/or peripancreatic tissues on CT scan or when a sample from the collection/necrosis contains pus or is positive for bacteria and/or fungi on Gram stain or culture.
Measured: From date of randomization until 30 days after randomization
Number of participants with systemic inflammatory response syndrome
At least 2 criteria: A) pulse >90 beats/min, B) respirations >20/min or arterial blood PaCO2 <32 mm Hg, C) temperature <36°C or >38°C, D) white blood cell count <4,000 cells/mm3 or >12,000 cells/mm3 or >10% bands
Measured: At 24 and 48 hours
Number of systemic inflammatory response syndrome criteria
The criteria are: A) pulse >90 beats/min, B) respirations >20/min or arterial blood PaCO2 <32 mm Hg, C) temperature <36°C or >38°C, D) white blood cell count <4,000 cells/mm3 or >12,000 cells/mm3 or >10% bands
Measured: At 24 and 48 hours
PAN-PROMISE symptom scale
PAN-PROMISE scale: a 7-symptom scale patient-reported outcome (range, 0 to 10 for each symptom; overall range, 0 to 70, with higher scores indicating higher symptom intensity). Details: https://doi.org/10.1136/gutjnl-2020-320729
Measured: At 24 and 48 hours (final value and change from baseline)
Time to oral refeeding
Days from baseline to oral refeeding
Measured: From date of randomization until 30 days after randomization
Number of participants with invasive treatment
Any of the following: thoracocentesis due to pancreatitis-induced pleural effusion, percutaneous and/or endoscopic drainage of pancreatic or peripancreatic fluid collections or necrosis, endoscopic or surgical necrosectomy, endoscopic retrograde cholangiopancreatography due to A) ruptured common bile duct, B) jaundice caused by compression of the common bile duct, C) main pancreatic duct leakage
Measured: From date of randomization until 30 days after randomization
Number of participants with nutritional support
Use of enteral (nasogastric or nasojejunal) or parenteral feeding
Measured: From date of randomization until 30 days after randomization
Number of participants with intensive care unit admission
Admission in the intensive care unit
Measured: From date of randomization until 30 days after randomization
Number of participants with exacerbation of coexisting condition
Exacerbation of pre-existing co-morbidity. The definition provided by the Revised Atlanta Classification is " Exacerbation of pre-existing co-morbidity, such as coronary artery disease or chronic lung disease, precipitated by the acute pancreatitis is defined as a systemic complication. In this document, we distinguish between persistent organ failure (the defining feature of severe acute pancreatitis) and other systemic complications, which are an exacerbation of pre-existing co-morbid disease." (revised Atlanta classification: https://doi.org/10.1136/gutjnl-2012-302779) For the WATERLAND trial we define exacerbation of pre-existing co-morbidity as
Measured: From date of randomization until 30 days after randomization
Number of participants with any organ failure
Definition according to the revised Atlanta classification (https://doi.org/10.1136/gutjnl-2012-302779): organ failure is defined by the presence of any of the following criteria: A) kidney failure as a creatinine ≥1.9 mg/dL or >170 micromol/L, B) cardiovascular failure as a systolic blood pressure <90 mmHg despite fluid resuscitation, and C) respiratory failure as a PaO2/FIO2≤300
Measured: From date of randomization until 30 days after randomization
Number of participants with persistent organ failure
Organ failure lasting more than 48h (revised Atlanta classification: https://doi.org/10.1136/gutjnl-2012-302779)
Measured: From date of randomization until 30 days after randomization
Number of participants with shock
Systolic blood pressure <90 mmHg despite fluid resuscitation (revised Atlanta classification: https://doi.org/10.1136/gutjnl-2012-302779)
Measured: From date of randomization until 30 days after randomization
Number of participants with respiratory failure
PaO2/FIO2≤300 (revised Atlanta classification: https://doi.org/10.1136/gutjnl-2012-302779)
Measured: From date of randomization until 30 days after randomization
Number of participants with kidney failure
Creatinine ≥1.9 mg/dL or >170 micromol/L (revised Atlanta classification: https://doi.org/10.1136/gutjnl-2012-302779)
Measured: From date of randomization until 30 days after randomization
Mortality (number of participants)
Death
Measured: From date of randomization until 30 days after randomization
Hospital stay
Days from recruitment to discharge from index admission
Measured: From date of randomization until 30 days after randomization
C-reactive protein
C-reactive protein blood levels
Measured: At 48 hours from randomization
Number of participants with hypovolemia
WATERFALL trial criteria for hypovolemia (see https://www.nejm.org/doi/10.1056/NEJMoa2202884)
Measured: At 24 and 48 hours from randomization
Number of participants with fluid overload
WATERFALL trial criteria for fluid overload (see https://www.nejm.org/doi/10.1056/NEJMoa2202884)
Measured: From randomization to 72 h thereafter
Number of participants with acute kidney injury
KDIGO criteria: increase in serum creatinine of ≥0.3 mg/dL within 48 hr or ≥50% within 7 days or urine output of <0.5 mL/kg/hr for >6 hr (https://doi.org/10.1159/000339789)
Measured: At 24 and 48 hours from randomization
Number of participants with hyperkalemia
Venous potassium>5mEq/L
Measured: At 24 and 48 hours from randomization
Number of participants with hypercalcemia
Venous calcium corrected by proteins>10.5mg/dL or 2.62 mmol/L
Measured: At 24 and 48 hours from randomization
Number of participants with hyperchloremia
Venous chloride>106mEq/L
Measured: At 24 and 48 hours from randomization
Number of participants with acidosis
Venous blood pH <7.35
Measured: At 24 and 48 hours from randomization
Number of participants with hyperchloremic acidosis
Patients with venous chloride>106mEq/L and venous blood pH <7.35
Measured: At 24 and 48 hours from randomization
Number of participants with composite safety outcome (primary safety outcome)
Fluid overload or acute kidney injury or hyperkalemia or hypercalcemia or hyperchloremia or acidosis
Measured: At 24 and 48 hours from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start19 Jun 2023
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 812 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enrique de-Madaria
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Universidad Miguel Hernandez de Elche, Hospital del Mar, Hospital Clinico Universitario de Santiago, Hospital Clínico Universitario de Valencia, Hospital Costa del Sol, Corporacion Parc Tauli, Hospital Clínico Universitario Lozano Blesa, Hospital General Universitario Gregorio Marañon, Hospital Universitario La Fe, Hospital Miguel Servet, Hospital Universitario Ramon y Cajal, Hospital Universitario Insular Gran Canaria, University Hospital Virgen de las Nieves, Hospital Universitario de Burgos, Hospital Universitario Lucus Augusti, Hospital Universitario Marqués de Valdecilla, Hospital Universitario Puerta del Mar, Instituto de Investigación Sanitaria Hospital Universitario de la Princesa, Hospital Universitario de Gran Canaria Doctor Negrín, Hospital Regional de Alta Especialidad del Bajio, Asian Institute Of Medical Sciences, Hospital Dr. Jaime Mendoza Sucre Bolivia, Hayatabad Medical Complex, University Hospital Olomouc, SIDS Hospital & Research Centre Gujarat India, Sanatorio Allende, University Hospital Bratislava, University Hospital Sestre Milosrdnice, Attikon Hospital, Nuevo Hospital Iturraspe Santa Fe Argentina, Hospital Nacional Rosales, Zagazig University, University of Utah, Hospitales Universitarios Virgen del Rocío, University Hospital of Girona Dr. Josep Trueta, Hospital of Navarra, Hospital Clínico Universitario de Valladolid, Hospital Universitario Central de Asturias, Kalinga Hospital, Bhubaneswar, Ohio State University, Zhengzhou University, Jinling Hospital, China, Hospital Privado de Cordoba, Argentina, Prince of Wales Hospital, Shatin, Hong Kong, Postgraduate Institute of Medical Education and Research in Chandigarh, RML Specialty Hospital, Wannan Medical College Yijishan Hospital, Bucharest Emergency Hospital, The First Affiliated Hospital of Henan University of Science and Technology, Emergency County Hospital Pius Brinzeu; Timisoara, Romania, King Hamad University Hospital, Bahrain
- Responsible party
- Sponsor-investigator, Enrique de-Madaria, Hospital General Universitario de Alicante
- Investigators
- Enrique de-Madaria, MD PhD, Principal investigator, Dr. Balmis General University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781243
- Sponsor's protocol ID
- Eudract 2023-000010-18
- Acronym
- WATERLAND
- Status last verified
- Aug 2026
- First submitted
- 25 Feb 2023
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Members of the ERICA consortium that recruited patients in the WATERLAND trial may claim access to the final dataset to perform post-hoc studies; these proposals will be studied by the steering committee.
Publications
Banks 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 23100216de-Madaria E, Buxbaum JL, Maisonneuve P, Garcia Garcia de Paredes A, Zapater P, Guilabert L, Vaillo-Rocamora A, Rodriguez-Gandia MA, Donate-Ortega J, Lozada-Hernandez EE, Collazo Moreno AJR, Lira-Aguilar A, Llovet LP, Mehta R, Tandel R, Navarro P, Sanchez-Pardo AM, Sanchez-Marin C, Cobreros M, Fernandez-Cabrera I, Casals-Seoane F, Casas Deza D, Lauret-Brana E, Marti-Marques E, Camacho-Montano LM, Ubieto V, Ganuza M, Bolado F; ERICA Consortium. Aggressive or Moderate Fluid Resuscitation in Acute Pancreatitis. N Engl J Med. 2022 Sep 15;387(11):989-1000. doi: 10.1056/NEJMoa2202884.
PubMed 36103415de-Madaria E, Sanchez-Marin C, Carrillo I, Vege SS, Chooklin S, Bilyak A, Mejuto R, Mauriz V, Hegyi P, Marta K, Kamal A, Lauret-Brana E, Barbu ST, Nunes V, Ruiz-Rebollo ML, Garcia-Rayado G, Lozada-Hernandez EE, Pereira J, Negoi I, Espina S, Hollenbach M, Litvin A, Bolado-Concejo F, Vargas RD, Pascual-Moreno I, Singh VK, Mira JJ. Design and validation of a patient-reported outcome measure scale in acute pancreatitis: the PAN-PROMISE study. Gut. 2021 Jan;70(1):139-147. doi: 10.1136/gutjnl-2020-320729. Epub 2020 Apr 3.
PubMed 32245906Guilabert L, Cardenas-Jaen K, Vaillo-Rocamora A, Garcia Garcia de Paredes A, Chhoda A, Sheth SG, Lopez-Valero C, Zapater P, Navarrete-Munoz EM, Maisonneuve P, Hernandez-Barco YG, Capurso G, Buxbaum JL, de-Madaria E; ERICA consortium. Normal saline versus lactated Ringer's solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial study protocol. Trials. 2024 Oct 21;25(1):699. doi: 10.1186/s13063-024-08539-2.
PubMed 39434191
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Saline Versus Lactated Ringer's Solution for Acute Pancreatitis Resuscitation, an Open-label Multicenter Randomized Controlled Trial: the WATERLAND Trial
- ClinicalTrials.gov ID
- NCT05781243
- Acronym / sponsor ID
- WATERLAND / Eudract 2023-000010-18
- Conditions
- Acute Pancreatitis
- Keywords
- Normal saline, Lactated Ringer solution, Acute pancreatitis, Fluid Therapy, Fluid resuscitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 812 participants (actual)
- Lead sponsor
- Enrique de-MadariaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Universidad Miguel Hernandez de Elche, Hospital del Mar, Hospital Clinico Universitario de Santiago, Hospital Clínico Universitario de Valencia, Hospital Costa del Sol, Corporacion Parc Tauli, Hospital Clínico Universitario Lozano Blesa, Hospital General Universitario Gregorio Marañon, Hospital Universitario La Fe, Hospital Miguel Servet, Hospital Universitario Ramon y Cajal, Hospital Universitario Insular Gran Canaria, University Hospital Virgen de las Nieves, Hospital Universitario de Burgos, Hospital Universitario Lucus Augusti, Hospital Universitario Marqués de Valdecilla, Hospital Universitario Puerta del Mar, Instituto de Investigación Sanitaria Hospital Universitario de la Princesa, Hospital Universitario de Gran Canaria Doctor Negrín, Hospital Regional de Alta Especialidad del Bajio, Asian Institute Of Medical Sciences, Hospital Dr. Jaime Mendoza Sucre Bolivia, Hayatabad Medical Complex, University Hospital Olomouc, SIDS Hospital & Research Centre Gujarat India, Sanatorio Allende, University Hospital Bratislava, University Hospital Sestre Milosrdnice, Attikon Hospital, Nuevo Hospital Iturraspe Santa Fe Argentina, Hospital Nacional Rosales, Zagazig University, University of Utah, Hospitales Universitarios Virgen del Rocío, University Hospital of Girona Dr. Josep Trueta, Hospital of Navarra, Hospital Clínico Universitario de Valladolid, Hospital Universitario Central de Asturias, Kalinga Hospital, Bhubaneswar, Ohio State University, Zhengzhou University, Jinling Hospital, China, Hospital Privado de Cordoba, Argentina, Prince of Wales Hospital, Shatin, Hong Kong, Postgraduate Institute of Medical Education and Research in Chandigarh, RML Specialty Hospital, Wannan Medical College Yijishan Hospital, Bucharest Emergency Hospital, The First Affiliated Hospital of Henan University of Science and Technology, Emergency County Hospital Pius Brinzeu; Timisoara, Romania, King Hamad University Hospital, Bahrain
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 23 Mar 2023 (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.
Background: Some evidence suggests that fluid resuscitation with lactated Ringer's solution (LR) may have an anti-inflammatory effect on acute pancreatitis (AP) when compared to normal saline (NS), and may be associated with a decrease in severity, but existing single center randomized controlled trials showed conflicting results. The WATERLAND trial aims to investigate the efficacy and safety of fluid resuscitation using LR compared to NS in patients with AP.
Methods: The WATERLAND trial is an international multicenter, open-label, parallel-group, randomized, controlled, superiority trial. Patients will be randomly assigned in a 1:1 ratio to receive LR versus NS-based fluid resuscitation for at least 48 hours. The primary outcome will be moderately severe or severe AP, according to the revision of the Atlanta classification. The secondary objectives of the WATERLAND trial are to determine the effect of LR versus NS fluid resuscitation on several efficacy and safety outcomes in patients with AP.
A total sample of 720 patients, 360 in the LR group and 360 in the NS group, will achieve 90% power to detect a difference between the group proportions of 10%, assuming that the frequency of moderately severe or severe AP in the LR group will be 17%. A loss to follow-up of 10% of patients is expected, so the total sample size will be 396 patients in each treatment arm (792 patients overall). The test statistic used is the two-sided Z test with pooled variance set at a 0.05 significance level.
Discussion: The WATERLAND study aims to improve the early management of AP. Fluid resuscitation is an inexpensive treatment available in any hospital center worldwide. If a better evolution of pancreatitis is demonstrated in one of the treatment arms, it would have important repercussions in the management of this frequent disease.
Detailed description
The entire protocol is published in open-access format, including the Statistical Analysis plan, in the journal Trials: https://doi.org/10.1186/s13063-024-08539-2
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactated Ringer solution (LR) | Experimental | Drug: Lactated Ringer SolutionLR: Lactated Ringer solution. Patients in the LR treatment arm will receive fluid therapy based on lactated Ringer's solution for a minimum of 48 hours. |
| Normal saline (NS) | Active comparator | Drug: Normal salineNS: Normal Saline. Patients in the NS treatment arm will receive fluid therapy based on normal saline for a minimum of 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is 18 years or older
- Diagnosis of acute pancreatitis according to the revision of the Atlanta classification (Banks et al, Gut 2013), which requires at least two of the following three criteria: A) typical abdominal pain, B) increase in serum amylase or lipase levels higher than three times the upper limit of normality, and C) signs of acute pancreatitis in imaging
- Signature of informed consent
Key exclusion criteria (11 listed)
- New York Heart Association class II heart failure (slight limitation of physical activity; fatigue, palpitations, or dyspnea with ordinal physical activity) or worse, or ejection fraction <50% in the last echocardiography
- Decompensated cirrhosis (Child's class B or C)
- Hyper or hyponatremia (<135 or >145 mEq/L)
- Hyperkalemia (>5 mEq/L)
- Hypercalcemia (albumin or protein-corrected calcium >10.5 mg/dL or 2.62 mmol/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 Ringer SolutionPatients in the LR (Lactated Ringer solution) treatment arm will receive fluid therapy based on lactated Ringer's solution for a minimum of 48 hours. | Drug | Lactated Ringer solution (LR) |
| Normal salinePatients in the NS (Normal Saline) treatment arm will receive fluid therapy based on lactated Ringer's solution for a minimum of 48 hours. | Drug | Normal saline (NS) |
Primary outcome
Number of Participants with moderately severe or severe acute pancreatitis
Time frame: From date of randomization until 30 days after randomization
Presence of local complications, exacerbation of previous comorbidity or organ failure, according to the definitions of these complications provided by the revised Atlanta Classification (https://doi.org/10.1136/gutjnl-2012-302779)
28 secondary outcomes
Number of participants with local complications
Time frame: From date of randomization until 30 days after randomization
Number of participants with necrotizing pancreatitis
Time frame: From date of randomization until 30 days after randomization
Number of participants with infection of pancreatic collections or necrosis
Time frame: From date of randomization until 30 days after randomization
Number of participants with systemic inflammatory response syndrome
Time frame: At 24 and 48 hours
Number of systemic inflammatory response syndrome criteria
Time frame: At 24 and 48 hours
PAN-PROMISE symptom scale
Time frame: At 24 and 48 hours (final value and change from baseline)
Time to oral refeeding
Time frame: From date of randomization until 30 days after randomization
Number of participants with invasive treatment
Time frame: From date of randomization until 30 days after randomization
Number of participants with nutritional support
Time frame: From date of randomization until 30 days after randomization
Number of participants with intensive care unit admission
Time frame: From date of randomization until 30 days after randomization
Number of participants with exacerbation of coexisting condition
Time frame: From date of randomization until 30 days after randomization
Number of participants with any organ failure
Time frame: From date of randomization until 30 days after randomization
Number of participants with persistent organ failure
Time frame: From date of randomization until 30 days after randomization
Number of participants with shock
Time frame: From date of randomization until 30 days after randomization
Number of participants with respiratory failure
Time frame: From date of randomization until 30 days after randomization
Number of participants with kidney failure
Time frame: From date of randomization until 30 days after randomization
Mortality (number of participants)
Time frame: From date of randomization until 30 days after randomization
Hospital stay
Time frame: From date of randomization until 30 days after randomization
C-reactive protein
Time frame: At 48 hours from randomization
Number of participants with hypovolemia
Time frame: At 24 and 48 hours from randomization
Number of participants with fluid overload
Time frame: From randomization to 72 h thereafter
Number of participants with acute kidney injury
Time frame: At 24 and 48 hours from randomization
Number of participants with hyperkalemia
Time frame: At 24 and 48 hours from randomization
Number of participants with hypercalcemia
Time frame: At 24 and 48 hours from randomization
Number of participants with hyperchloremia
Time frame: At 24 and 48 hours from randomization
Number of participants with acidosis
Time frame: At 24 and 48 hours from randomization
Number of participants with hyperchloremic acidosis
Time frame: At 24 and 48 hours from randomization
Number of participants with composite safety outcome (primary safety outcome)
Time frame: At 24 and 48 hours from randomization
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 18 Aug 2026.
- Background: PubMed 23100216Banks 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.
- Background: PubMed 36103415de-Madaria E, Buxbaum JL, Maisonneuve P, Garcia Garcia de Paredes A, Zapater P, Guilabert L, Vaillo-Rocamora A, Rodriguez-Gandia MA, Donate-Ortega J, Lozada-Hernandez EE, Collazo Moreno AJR, Lira-Aguilar A, Llovet LP, Mehta R, Tandel R, Navarro P, Sanchez-Pardo AM, Sanchez-Marin C, Cobreros M, Fernandez-Cabrera I, Casals-Seoane F, Casas Deza D, Lauret-Brana E, Marti-Marques E, Camacho-Montano LM, Ubieto V, Ganuza M, Bolado F; ERICA Consortium. Aggressive or Moderate Fluid Resuscitation in Acute Pancreatitis. N Engl J Med. 2022 Sep 15;387(11):989-1000. doi: 10.1056/NEJMoa2202884.
- Background: PubMed 32245906de-Madaria E, Sanchez-Marin C, Carrillo I, Vege SS, Chooklin S, Bilyak A, Mejuto R, Mauriz V, Hegyi P, Marta K, Kamal A, Lauret-Brana E, Barbu ST, Nunes V, Ruiz-Rebollo ML, Garcia-Rayado G, Lozada-Hernandez EE, Pereira J, Negoi I, Espina S, Hollenbach M, Litvin A, Bolado-Concejo F, Vargas RD, Pascual-Moreno I, Singh VK, Mira JJ. Design and validation of a patient-reported outcome measure scale in acute pancreatitis: the PAN-PROMISE study. Gut. 2021 Jan;70(1):139-147. doi: 10.1136/gutjnl-2020-320729. Epub 2020 Apr 3.
- Background: PubMed 39434191Guilabert L, Cardenas-Jaen K, Vaillo-Rocamora A, Garcia Garcia de Paredes A, Chhoda A, Sheth SG, Lopez-Valero C, Zapater P, Navarrete-Munoz EM, Maisonneuve P, Hernandez-Barco YG, Capurso G, Buxbaum JL, de-Madaria E; ERICA consortium. Normal saline versus lactated Ringer's solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial study protocol. Trials. 2024 Oct 21;25(1):699. doi: 10.1186/s13063-024-08539-2.
- Published study protocol and statistical analysis planLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Members of the ERICA consortium that recruited patients in the WATERLAND trial may claim access to the final dataset to perform post-hoc studies; these proposals will be studied by the steering committee.
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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.
Enrique de-Madaria, MD PhD principal investigator
Dr. Balmis General University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lactated Ringer Solution and Normal saline in people with Acute Pancreatitis, run by Enrique de-Madaria at 1 site in Spain.
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 3 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: finished, as of the sponsor's last update on 18 Aug 2026. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of Participants with moderately severe or severe acute pancreatitis (time frame: From date of randomization until 30 days after randomization). 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 NCT05781243, which also lists 4 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 18 Aug 2026.