SYFc8ad9358068f46aaaa5cfad832e142ce

Not Yet RecruitingPhase 4

Normal saline versus lactated Ringer’s solution for fluid ad...

Semmelweis University Source

CTIS (EMA)

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Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

1

Brief Summary

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: not yet recruiting
Reported enrollment (type unavailable): Not reported
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 8, 2024
Actual (reported)

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (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.

Interventions

Ringer Laktát Hartmann „Baxter” oldatos infúzióType not reported

Nátrium-klorid EUROLIFE 0,9% oldatos infúzióType not reported

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

years of age
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

Sponsors & Collaborators

Semmelweis University
Otherlead

Study Sites (1)

Semmelweis University

Budapest VIII, 1083, Hungary

Péter Hegyi+3614591500 hegyi.peter@semmelweis.hu

Central Study Contacts

Tóth Dominika

+36303669194 toth.dominika@pte.hu

Study Design

Study Type: interventional
Phase: phase 4

Study Record Dates

First Submitted

March 8, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-511229-79-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 04:39:29 UTC

Locations

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Phase 4Completed

Signature of informed consent

You may not qualify if:

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
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)

Contact the study team to confirm eligibility.

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Locations

You may not qualify if: