Normal saline versus lactated Ringer’s solution for fluid administration in acute pancreatitis, an open-label multicenter randomized controlled trial: the WATERLAND trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Semmelweis University

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Decision date (initial)

2024-05-17

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Dose response, Safety, Therapy

The WATERLAND study aims to improve the early management of AP. Fluid therapy 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 a great influence on the treatment of this frequent disease.

Conditions and MedDRA coding

Acute Pancreatitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 18 years of age
2. 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
3. Signature of informed consent

Exclusion criteria 11

1. 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
2. Decompensated cirrhosis (Child’s class B or C)
3. Hyper or hyponatremia (<135 or >145 mEq/L)
4. Hyperkalemia (>5 mEq/L)
5. Hypercalcemia (albumin or protein-corrected calcium >10.5 mg/dL or 2.62 mmol/L)
6. 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
7. Signs of volume overload or heart failure at recruitment (peripheral edema, pulmonary rales, or increased jugular ingurgitation at 45º)
8. Time from pain onset to arrival to emergency room >24 h
9. Time from confirmation of pancreatitis to randomization >8 h
10. Chronic pancreatitis defined by a Wirsung duct ≥4mm and/or pancreatic calcifications
11. More than 1 previous episode of acute pancreatitis (only 2 episodes of acute pancreatitis are allowed, one of them the present episode)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary outcome will be moderately severe to severe AP, according to the revision of the Atlanta classification. The primary safety outcome will be a composite variable involving any of the following: fluid overload, acute kidney injury, hyperkalemia, hypercalcemia, or acidosis.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Semmelweis University

Sponsor organisation

Semmelweis University

Address

Tomo Utca 25-29

City

Budapest VIII

Postcode

1083

Country

Hungary

Scientific contact point

Organisation

Semmelweis University

Contact name

Tóth Dominika

Public contact point

Organisation

Semmelweis University

Contact name

Tóth Dominika

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications