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NORMAL SALINE VERSUS LACTATED RINGER’S SOLUTION FOR ACUTE PANCREATITIS RESUSCITATION, AN OPEN‑LABEL MULTICENTER RANDOMIZED CONTROLLED TRIAL: THE WATERLAND TRIAL

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NORMAL SALINE VERSUS LACTATED RINGER’S SOLUTION FOR ACUTE PANCREATITIS RESUSCITATION, AN OPEN‑LABEL MULTICENTER RANDOMIZED CONTROLLED TRIAL: THE WATERLAND TRIAL

Enrique de-Madaria 1, Lucía Guilabert 1, Natalia Corzo Zamora 2, Andrea Ossio 2, Dhvani D. Adhvaryu 3, Rajiv Mehta 3, Inmaculada Ortiz Polo 4, Adolfo del Val Antonana 4, Monica Otero-Iglesias 5, Martiño Loureiro-Veira 5, Patricia de Miguel Mancebo 6, Cristina Saldaña-Dueñas 6, Virginia Flores 7, Ana Isabel Hernando Alonso 7, Enrique Ceamanos-Ibarra 8, Guillermo García-Rayado 8, Eva Marti Marques 9, María Gómez-Rivas 9, Édgar E. Lozada Hernández 10, Wiqas Ahmad 11, Sher Rehman 11, Muhammad Sadik 12, Bibi Faiza 12, Leandro Pierini 13, Pablo Navarro Cortés 14, LUCÍA MAJANO 15, Eugenia Lauret-Braña 16, Carlos Rodríguez Pérez 17, Salem Youssef Mohamed 18, Lu Ke 19, Bo Ye 19, Tudor Voicu Moga 20, Suprabhat Giri 21, alba hidalgo 22, Fernando Casals Seoane 23, Daryl Ramai 24, Maria Lourdes Ruiz Rebollo 25, Georgios Papachristou 26, Szilárd Váncsa 27, Arpad Panyko 28, Karina Cárdenas-Jaén 1, Patrick Maisonneuve 29, Yasmin G. Hernandez-Barco 30, Gabriele Capurso 31, Pedro Zapater 1, Eva-María Navarrete-Muñoz 32, Alicia Vaillo-Rocamora 1, James L. Buxbaum 33

Affiliations

1 Hospital General Universitario Dr. Balmis-ISABIAL, Alicante, Spain

2 Hospital del Norte, Cochabamba, Bolivia, Plurinational State of

3 Surat Institute of Digestive Sciences (SIDS) Hospital and Research Centre, Surat, Gujarat, India

4 Hospital Universitario y Politécnico la Fé, Valencia, Spain

5 Hospital Clínico Universitario Santiago de Compostela, Instituto de Investigación Santiago de Compostela (IDIS), Santiago de Compostela, Spain

6 Hospital Universitario de Navarra, Pamplona, Spain

7 Hospital General Universitario Gregorio Marañón, Madrid, Spain

8 Hospital Clínico Universitario Lozano Blesa, Zaragoza, España. Instituto de Investigación Sanitaria de Aragón (IIS Aragón), Zaragoza, Spain, Spain

9 Hospital Universitario Lucus Augusti, Lugo, Spain

10 Servicios de Salud del Instituto Mexicano del Seguro Social para el Bienestar (IMSS-BIENESTAR) Hospital Regional de Alta Especialidad del Bajio, León, Mexico

11 Hayatabad Medical Complex, Peshawar, Pakistan

12 Asian institute of medical science, Hyderabad Sindh, Pakistan

13 "J. B. Iturraspe" Hospital, Santa Fe, Argentina

14 Hospital Clínico Universitario de Valencia, Valencia, Spain

15 Hospital Universitario Ramon y Cajal, Madrid, Spain

16 Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain

17 Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas de Gran Canaria, Spain

18 Zagazig University, Egypt, Zagazig, Egypt

19 Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Jiangsu, China

20 Center for Advanced Research in Gastroenterology and Hepatology, "Victor Babeș" University of Medicine and Pharmacy, Timișoara, România, "Pius Brânzeu" Clinical Emergency County Hospital Timișoara, România, Timisoara, Romania

21 Kalinga Institute Of Medical Sciences, Bhubanewar, India

22 Hospital Universitario Puerta del Mar, Cádiz, Spain

23 Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain

24 University of Utah, Salt Lake, Utah, United States

25 Hospital Clínico Universitario de Valladolid, Valladolid, Spain

26 The Ohio State University, Columbus, Ohio, United States

27 Centre for Translational Medicine and Institute for Pancreatic Diseases, Semmelweis University, Budapest, Hungary

28 Faculty of Medicine, Comenius University, Bratislava, Slovakia

29 IRCSS European Institute of Oncology, Milan, Italy

30 Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States

31 Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute IRCCS, Vita-Salute San Raffaele University, Milan, Italy

32 Miguel Hernandez University-ISABIAL, Alicante, Spain

33 University of Southern California, Los Angeles, United States

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Abstract

Introduction

Some evidence suggests that fluid resuscitation with lactated Ringer’s solution (LR) may have an anti-inflammatory effect on acute pancreatitis (AP) ^{1 2}when compared to normal saline (NS). A meta-analysis of randomized studies described that using LR was associated with less severity, less need for admission to the intensive care unit, and less frequent local complications ³, but existing single-center randomized controlled trials show conflicting results.

Aims & Methods

The WATERLAND trial is a multicenter, open-label, randomized, controlled, superiority trial. Patients were randomly assigned in a 1:1 ratio to receive LR versus NS-based fluid resuscitation (following the WATERFALL moderate volume strategy ⁴) for at least 48 hours. The primary outcome was moderately severe or severe AP (MSAP). The secondary objectives were to determine the effect of LR versus NS fluid resuscitation on several efficacy and safety outcomes. A total sample of 720 patients was calculated to achieve 90% power to detect a difference between the group proportions of 10%, assuming that the frequency of MSAP in the LR group is 17%, and 27% in the NS group ³. A loss to follow-up of 10% of patients was expected, so the total sample size was 396 patients in each treatment arm (792 patients overall).

Results

A total of 792 patients from 43 centers across 18 countries from the 5 continents were included (399 were randomized to LR and 393 to NS). The frequency of MSAP in the LR group vs. the NS group was 23.3% vs. 25.2%, p=0.536 (Table 1). LR was robustly associated with significantly reduced inflammation, showing both a lower frequency of systemic inflammatory response syndrome at 24 and 48h, and lower serum C-reactive protein levels at 48h (Table 1). NS was associated with a significantly higher frequency of acidosis and hyperchloremic acidosis at 24 and 48h (Table 1). No differences were observed in other efficacy or safety outcomes, including local complications, necrosis, infection of necrosis, need for invasive treatment, need for nutritional support, intensive care unit admission, organ failure, hospital stay, fluid overload, hypercalcemia, hyperkalemia, mortality or PAN-PROMISE AP symptom score.

Table 1. Arm of treatment and selected outcomes.

Variable	Lactated Ringer N=399	Normal saline N=393	p	Relative Risk (95% confidence interval)
Moderately severe or severe (primary outcome) n (%)	93 (23.3)	99 (25.2)	0.536	0.925 (0.723-1.184)
Systemic inflammatory response syndrome at 24h n (%)	57 (14.3)	80 (20.4)	0.024	0.702 (0.515-0.957)
Systemic inflammatory response syndrome at 48h n (%) 1 missing	47 (11.8)	67 (17.1)	0.033	0.689 (0.488-0.974)
C-reactive protein at 48h Median (IQR), mg/L 13 missings	81 (19-193)	112 (42-228)	0.005	0.918 (0.849-0.993)*
Acidosis at 24h n (%) 34 missings	60 (15.7)	96 (25.6)	<0.001	0.612 (0.458-0.817)
Acidosis at 48h n (%) 43 missings	56 (14.8)	82 (22.1)	0.010	0.670 (0.493-0.912)
Hyperchloremic acidosis at 24h n (%) 42 missings	28 (7.4)	60 (16.2)	<0.001	0.457 (0.299-0.699)
Hyperchloremic acidosis at 48h n (%) 55 missings	21 (5.7)	54 (14.7)	<0.001	0.386 (0.238-0.625)

* Comparison of high values (above the median) to low values (at or below the median)

Conclusion

Lactated Ringer's solution consistently has an anti-inflammatory effect in patients with acute pancreatitis and is associated with a lower incidence of acidosis and hyperchloremic acidosis. Nevertheless, these benefits do not lead to improvements in key clinical outcomes, including symptom intensity, disease severity, local or systemic complications, length of hospital stay, or mortality. The WATERLAND trial stands as the largest and most globally representative randomized clinical trial conducted in acute pancreatitis to date.

References

1. Wu BU, Hwang JQ, Gardner TH, et al. 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.
2. de-Madaria E, Herrera-Marante I, González-Camacho V, et al. Fluid resuscitation with lactated Ringer's solution vs normal saline in acute pancreatitis: A triple-blind, randomized, controlled trial. United European Gastroenterol J. 2018 Feb;6(1):63-72. doi: 10.1177/2050640617707864.
3. Zhou S, Buitrago C, Foong A, et al. Comprehensive meta-analysis of randomized controlled trials of Lactated Ringer's versus Normal Saline for acute pancreatitis. Pancreatology. 2021 Dec;21(8):1405-1410. doi: 10.1016/j.pan.2021.07.003.
4. de-Madaria E, Buxbaum JL, Maisonneuve P, et al (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.

Event

UEG Week Berlin 2025

Topics

Pancreas

Submission format

Abstract

Session

From The Lion King to Waterland: A journey through pancreatitis

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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