Studies comparing aggressive hydration with lactate Ringer: study protocol design

Author (country, year) [ref]Study designInfusion protocolComparisonNumber ptsFemale gender (%)Mean age (yrs ± SD)Patient related PEP riskExclusion criteria
Buxbaum et al. (USA, 2014) [30]RCT (2:1), multicentre3.0 mL/(kg h) during and for 8 h after ERCP, bolus of 20 mL/kg immediately after the procedureStandard hydration [LR 1.5 mL/(kg h) during and for 8 h after ERCP, without bolus]39 aggressive hydration
23 standard hydration
56.5 vs. 48.745 ± 17 vs. 43 ± 14Low and average riskPrevious sphincterotomy
Active pancreatitis
Cholangitis
Chronic pancreatitis
Fluid overload increased risk*
Electrolyte alterations
Pregnancy
Age > 70 yrs
Shaygan-Nejad et al. (Iran, 2015) [32]RCT (1:1), monocentre3.0 mL/(kg h) during and for 8 h after ERCP, bolus of 20 mL/kg immediately after the procedureStandard hydration [LR 1.5 mL/(kg h) during and for 8 h after ERCP, without bolus]75 aggressive hydration
75 standard hydration
64 vs. 6850.8 ± 13.5 overallLow and average riskPrevious sphincterotomy
Active pancreatitis
Cholangitis
Chronic pancreatitis
Fluid overload increased risk*
Electrolyte alterations
Pregnancy
Age > 70 yrs
Choi et al. (Korea, 2017) [31]RCT (1:1), multicentre3.0 mL/(kg h) during and for 8 h after ERCP, bolus of 10 mL/kg before and immediately after the procedureStandard hydration [LR 1.5 mL/(kg h) during and for 8 h after ERCP, without bolus]255 aggressive hydration
255 standard hydration
45.5 vs. 45.157.0 ± 11.9 vs. 58.2 ± 12.4Average and high riskPrevious sphincterotomy
Active pancreatitis
Chronic pancreatitis
Fluid overload increased risk*
Electrolyte alterations
Age < 18 and > 75 yrs
Post-surgical anatomy
Park et al. (Korea, 2018) [34]RCT (1:1:1), multicentre3.0 mL/(kg h) during and for 8 h after ERCP, bolus of 20 mL/kg immediately after the procedurea. Aggressive hydration NSS
b. Standard hydration LR
132 aggressive LR
134 aggressive NSS
129 standard LR
53 vs. 56 vs. 5559.0 ± 15.1 vs. 58.1 ± 15.5 vs. 58.9 ± 15.1Average and high riskPrevious sphincterotomy
Sepsis
Active pancreatitis
Chronic pancreatitis
Fluid overload increased risk*
Electrolyte alterations
Age < 20 and > 80 yrs
Masjedizadeh et al. (Iran, 2017) [36]RCT (1:1:1), monocentre3.0 mL/(kg h) for 8 h after ERCP, bolus of 20 mL/kg immediately after the procedurea. Indomethacin 50 mg before and 50 mg after ERCP
b. Nothing
62 aggressive LR
62 indomethacin
62 nothing
48.4 vs. 61.3 vs. 54.859.0 ± 15.1 vs. 58.1 ± 15.5 vs. 58.9 ± 15.1Low and average riskPrevious sphincterotomy
Active pancreatitis
Cholangitis
Sepsis
Chronic pancreatitis
Fluid overload increased risk*
Pregnancy
Balloon dilation of papilla
Pancreatic stent
Ghaderi et al. (Iran, 2019) [33]RCT (1:1), monocentre3.0 mL/(kg h) for 8 h after ERCP, bolus of 20 mL/kg after the procedureStandard hydration [LR 1.5 mL/(kg h) during and for 8 h after ERCP, without bolus]120 aggressive hydration
120 standard hydration
51.6 vs. 52.551.57 ± 13.5 overallLow and average riskPrevious sphincterotomy
Active pancreatitis
Cholangitis
Sepsis
Chronic pancreatitis
Fluid overload increased risk*
Electrolyte alterations
Pregnancy
Age > 70 yrs
Guha et al. (India, 2023) [37]RCT (1:1), monocentre3.0 mL/(kg h) for 8 h after ERCP, bolus of 20 mL/kg after the procedureIndomethacin 100 mg endorectal178 aggressive hydration
174 indomethacin
69.9 vs. 71.344.0 ± 14.5 overallLow and average riskActive pancreatitis
Chronic pancreatitis
Fluid overload increased risk*
Electrolyte alterations
Pregnancy
Breastfeeding
Age > 70 yrs
NSAIDs therapy in prior 7 days
Chang et al. (Thailand, 2022) [35]RCT (1:1), monocentre3,600 mL LR in 24 h starting 2 h before ERCPStandard hydration100 aggressive hydration
100 control group
47 vs. 4950.9 ± 10.6 vs. 50.4 ± 12.6Low and average riskActive pancreatitis
Chronic pancreatitis
Fluid overload increased risk*
Electrolyte alterations
Pregnancy
Age > 65 yrs
Post-surgical anatomy

*: Cardiac, hepatic, respiratory, or renal insufficiency/severe disease; ERCP: endoscopic retrograde cholangiopancreatography; LR: lactated Ringer’s; NSAIDs: non-steroidal anti-inflammatory drugs; NSS: normal saline solution; PEP: post-ERCP acute pancreatitis; pts: patients; RCTs: randomized controlled trials; yrs: years