Normal saline versus lactated Ringer's solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial study protocol.
Humans
Ringer's Lactate
/ administration & dosage
Pancreatitis
/ therapy
Fluid Therapy
/ methods
Saline Solution
/ administration & dosage
Multicenter Studies as Topic
Treatment Outcome
Resuscitation
/ methods
Acute Disease
Equivalence Trials as Topic
Adult
Male
Randomized Controlled Trials as Topic
Female
Middle Aged
Time Factors
Acute pancreatitis
Fluid resuscitation
Lactated Ringer solution
Normal saline
Randomized controlled trial
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
21 Oct 2024
21 Oct 2024
Historique:
received:
26
07
2024
accepted:
08
10
2024
medline:
22
10
2024
pubmed:
22
10
2024
entrez:
21
10
2024
Statut:
epublish
Résumé
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. 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 h. 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. 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. ClinicalTrials.gov, NCT05781243. Registration date on January 4, 2023. EudraCT number 2023-000010-18, first posted March 23, 2023.
Sections du résumé
BACKGROUND
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
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 h. 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
CONCLUSIONS
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.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov, NCT05781243. Registration date on January 4, 2023. EudraCT number 2023-000010-18, first posted March 23, 2023.
Identifiants
pubmed: 39434191
doi: 10.1186/s13063-024-08539-2
pii: 10.1186/s13063-024-08539-2
doi:
Substances chimiques
Ringer's Lactate
0
Saline Solution
0
Banques de données
ClinicalTrials.gov
['NCT05781243']
Types de publication
Journal Article
Clinical Trial Protocol
Langues
eng
Sous-ensembles de citation
IM
Pagination
699Informations de copyright
© 2024. The Author(s).
Références
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.
doi: 10.7326/0003-4819-158-3-201302050-00583
pubmed: 23295957
pmcid: 5114123
Peery AF, Crockett SD, Murphy CC, Jensen ET, Kim HP, Egberg MD, et al. Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States: update 2021. Gastroenterology. 2022;162(2):621–44.
doi: 10.1053/j.gastro.2021.10.017
pubmed: 34678215
Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, et al. Classification of acute pancreatitis–2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013;62(1):102–11.
doi: 10.1136/gutjnl-2012-302779
pubmed: 23100216
Sternby H, Bolado F, Canaval-Zuleta HJ, Marra-Lopez C, Hernando-Alonso AI, Del-Val-Antonana A, et al. Determinants of severity in acute pancreatitis: a nation-wide multicenter prospective cohort study. Ann Surg. 2019;270(2):348–55.
doi: 10.1097/SLA.0000000000002766
pubmed: 29672416
de-Madaria E, Sánchez-Marin C, Carrillo I, Vege SS, Chooklin S, Bilyak A, et al. Design and validation of a patient-reported outcome measure scale in acute pancreatitis: the PAN-PROMISE study. Gut. 2021;70(1):139–47.
doi: 10.1136/gutjnl-2020-320729
pubmed: 32245906
de-Madaria E, Mira JJ, Carrillo I, Afif W, Ang D, Antelo M, et al. The present and future of gastroenterology and hepatology: an international SWOT analysis (the GASTROSWOT project). Lancet Gastroenterol Hepatol. 2022;7(5):485–94.
doi: 10.1016/S2468-1253(21)00442-8
pubmed: 35247318
Garcia-Rayado G, Cardenas-Jaen K, de-Madaria E. Towards evidence-based and personalised care of acute pancreatitis. United European Gastroenterol J. 2020;8(4):403–9. https://doi.org/10.1177/2050640620903225 .
Singh VK, Moran RA, Afghani E, de-Madaria E. Treating acute pancreatitis: what’s new? Expert Rev Gastroenterol Hepatol. 2015;9(7):901–11.
doi: 10.1586/17474124.2015.1048225
pubmed: 25982517
de-Madaria E, Garg PK. Fluid therapy in acute pancreatitis - aggressive or adequate? Time for reappraisal. Pancreatology. 2014;14(6):433–5.
doi: 10.1016/j.pan.2014.09.008
pubmed: 25455538
de-Madaria E, Martinez JF, Aparicio JR, Lluis F. Aggressive fluid resuscitation in acute pancreatitis: in aqua sanitas? Am J Gastroenterol. 2017;112(10):1617–8.
doi: 10.1038/ajg.2017.222
pubmed: 28978969
de-Madaria E, Martinez J, Perez-Mateo M. The dynamic nature of fluid resuscitation in acute pancreatitis. Clin Gastroenterol Hepatol. 2012;10(1):95–6. author reply 6.
doi: 10.1016/j.cgh.2011.08.020
pubmed: 21888883
de-Madaria E, Soler-Sala G, Sanchez-Paya J, Lopez-Font I, Martinez J, Gomez-Escolar L, et al. Influence of fluid therapy on the prognosis of acute pancreatitis: a prospective cohort study. Am J Gastroenterol. 2011;106(10):1843–50.
doi: 10.1038/ajg.2011.236
pubmed: 21876561
Singh VK, Gardner TB, Papachristou GI, Rey-Riveiro M, Faghih M, Koutroumpakis E, et al. An international multicenter study of early intravenous fluid administration and outcome in acute pancreatitis. United European Gastroenterol J. 2017;5(4):491–8.
doi: 10.1177/2050640616671077
pubmed: 28588879
de-Madaria E, Buxbaum JL, Maisonneuve P, Garcia Garcia de Paredes A, Zapater P, Guilabert L, et al. Aggressive or moderate fluid resuscitation in acute pancreatitis. N Engl J Med. 2022;387(11):989–1000.
doi: 10.1056/NEJMoa2202884
pubmed: 36103415
Gordon D, Spiegel R. Fluid resuscitation: history, physiology, and modern fluid resuscitation strategies. Emerg Med Clin North Am. 2020;38(4):783–93.
doi: 10.1016/j.emc.2020.06.004
pubmed: 32981617
Investigators SS, Australian and New Zealand Intensive Care Society Clinical Trials G, Australian Red Cross Blood S, George Institute for International H, Myburgh J, et al. Saline or albumin for fluid resuscitation in patients with traumatic brain injury. N Engl J Med. 2007;357(9):874–84.
doi: 10.1056/NEJMoa067514
Myburgh JA, Finfer S, Bellomo R, Billot L, Cass A, Gattas D, et al. Hydroxyethyl starch or saline for fluid resuscitation in intensive care. N Engl J Med. 2012;367(20):1901–11.
doi: 10.1056/NEJMoa1209759
pubmed: 23075127
de-Madaria E, Herrera-Marante I, Gonzalez-Camacho V, Bonjoch L, Quesada-Vazquez N, Almenta-Saavedra I, 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;6(1):63–72.
doi: 10.1177/2050640617707864
pubmed: 29435315
Wu BU, Hwang JQ, Gardner TH, Repas K, Delee R, Yu S, et al. Lactated Ringer’s solution reduces systemic inflammation compared with saline in patients with acute pancreatitis. Clin Gastroenterol Hepatol. 2011;9(8):710-7 e1.
doi: 10.1016/j.cgh.2011.04.026
pubmed: 21645639
Choosakul S, Harinwan K, Chirapongsathorn S, Opuchar K, Sanpajit T, Piyanirun W, et al. Comparison of normal saline versus lactated Ringer’s solution for fluid resuscitation in patients with mild acute pancreatitis, a randomized controlled trial. Pancreatology. 2018;18(5):507–12. https://doi.org/10.1016/j.pan.2018.04.016 .
doi: 10.1016/j.pan.2018.04.016
pubmed: 29754857
Lee A, Ko C, Buitrago C, Hiramoto B, Hilson L, Buxbaum J, et al. Lactated Ringers vs normal saline resuscitation for mild acute pancreatitis: a randomized trial. Gastroenterology. 2021;160(3):955-7 e4.
doi: 10.1053/j.gastro.2020.10.044
pubmed: 33159924
Karki B, Thapa S, Khadka D, Karki S, Shrestha R, Khanal A, et al. Intravenous Ringers lactate versus normal saline for predominantly mild acute pancreatitis in a Nepalese Tertiary Hospital. PLoS ONE. 2022;17(1): e0263221.
doi: 10.1371/journal.pone.0263221
pubmed: 35089964
pmcid: 9126573
Zhou S, Buitrago C, Foong A, Lee V, Dawit L, Hiramoto B, et al. Comprehensive meta-analysis of randomized controlled trials of lactated Ringer’s versus normal saline for acute pancreatitis. Pancreatology. 2021;21(8):1405–10.
doi: 10.1016/j.pan.2021.07.003
pubmed: 34332907
Semler MW, Self WH, Wanderer JP, Ehrenfeld JM, Wang L, Byrne DW, et al. Balanced crystalloids versus saline in critically ill adults. N Engl J Med. 2018;378(9):829–39.
doi: 10.1056/NEJMoa1711584
pubmed: 29485925
pmcid: 5846085
Young P, Bailey M, Beasley R, Henderson S, Mackle D, McArthur C, et al. Effect of a buffered crystalloid solution vs saline on acute kidney injury among patients in the intensive care unit: the SPLIT randomized clinical trial. JAMA. 2015;314(16):1701–10.
doi: 10.1001/jama.2015.12334
pubmed: 26444692
Finfer S, Micallef S, Hammond N, Navarra L, Bellomo R, Billot L, et al. Balanced multielectrolyte solution versus saline in critically ill adults. N Engl J Med. 2022;386(9):815–26.
doi: 10.1056/NEJMoa2114464
pubmed: 35041780
Committee ASoP, Jue TL, Storm AC, Naveed M, Fishman DS, Qumseya BJ, et al. ASGE guideline on the role of endoscopy in the management of benign and malignant gastroduodenal obstruction. Gastrointest Endosc. 2021;93(2):309-22 e4.
doi: 10.1016/j.gie.2020.07.063
Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179–84.
doi: 10.1159/000339789
pubmed: 22890468
Scheingraber S, Rehm M, Sehmisch C, Finsterer U. Rapid saline infusion produces hyperchloremic acidosis in patients undergoing gynecologic surgery. Anesthesiology. 1999;90(5):1265–70.
doi: 10.1097/00000542-199905000-00007
pubmed: 10319771
FDA. Collection of Race and Ethnicity Data in Clinical Trials Guidance for Industry and Food and Drug Administration Staff: FDA. ; 2016 [Available from: https://www.fda.gov/media/75453/download .
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)–a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81.
doi: 10.1016/j.jbi.2008.08.010
pubmed: 18929686
Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O’Neal L, et al. The REDCap consortium: building an international community of software platform partners. J Biomed Inform. 2019;95: 103208.
doi: 10.1016/j.jbi.2019.103208
pubmed: 31078660
pmcid: 7254481
Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts. BMC Med Res Methodol. 2017;17(1):162.
doi: 10.1186/s12874-017-0442-1
pubmed: 29207961
pmcid: 5717805
van Buuren S, Groothuis-Oudshoorn K. mice: multivariate imputation by chained equations in R. J Stat Softw. 2011;45(3):1–67.
doi: 10.18637/jss.v045.i03