Studies comparing aggressive hydration with lactate Ringer: study protocol design
Author (country, year) [ref] | Study design | Infusion protocol | Comparison | Number pts | Female gender (%) | Mean age (yrs ± SD) | Patient related PEP risk | Exclusion criteria |
---|---|---|---|---|---|---|---|---|
Buxbaum et al. (USA, 2014) [30] | RCT (2:1), multicentre | 3.0 mL/(kg h) during and for 8 h after ERCP, bolus of 20 mL/kg immediately after the procedure | Standard hydration [LR 1.5 mL/(kg h) during and for 8 h after ERCP, without bolus] | 39 aggressive hydration23 standard hydration | 56.5 vs. 48.7 | 45 ± 17 vs. 43 ± 14 | Low and average risk | Previous sphincterotomyActive pancreatitisCholangitisChronic pancreatitisFluid overload increased risk*Electrolyte alterationsPregnancyAge > 70 yrs |
Shaygan-Nejad et al. (Iran, 2015) [32] | RCT (1:1), monocentre | 3.0 mL/(kg h) during and for 8 h after ERCP, bolus of 20 mL/kg immediately after the procedure | Standard hydration [LR 1.5 mL/(kg h) during and for 8 h after ERCP, without bolus] | 75 aggressive hydration75 standard hydration | 64 vs. 68 | 50.8 ± 13.5 overall | Low and average risk | Previous sphincterotomyActive pancreatitisCholangitisChronic pancreatitisFluid overload increased risk*Electrolyte alterationsPregnancyAge > 70 yrs |
Choi et al. (Korea, 2017) [31] | RCT (1:1), multicentre | 3.0 mL/(kg h) during and for 8 h after ERCP, bolus of 10 mL/kg before and immediately after the procedure | Standard hydration [LR 1.5 mL/(kg h) during and for 8 h after ERCP, without bolus] | 255 aggressive hydration255 standard hydration | 45.5 vs. 45.1 | 57.0 ± 11.9 vs. 58.2 ± 12.4 | Average and high risk | Previous sphincterotomyActive pancreatitisChronic pancreatitisFluid overload increased risk*Electrolyte alterationsAge < 18 and > 75 yrsPost-surgical anatomy |
Park et al. (Korea, 2018) [34] | RCT (1:1:1), multicentre | 3.0 mL/(kg h) during and for 8 h after ERCP, bolus of 20 mL/kg immediately after the procedure | a. Aggressive hydration NSSb. Standard hydration LR | 132 aggressive LR134 aggressive NSS129 standard LR | 53 vs. 56 vs. 55 | 59.0 ± 15.1 vs. 58.1 ± 15.5 vs. 58.9 ± 15.1 | Average and high risk | Previous sphincterotomySepsisActive pancreatitisChronic pancreatitisFluid overload increased risk*Electrolyte alterationsAge < 20 and > 80 yrs |
Masjedizadeh et al. (Iran, 2017) [36] | RCT (1:1:1), monocentre | 3.0 mL/(kg h) for 8 h after ERCP, bolus of 20 mL/kg immediately after the procedure | a. Indomethacin 50 mg before and 50 mg after ERCPb. Nothing | 62 aggressive LR62 indomethacin62 nothing | 48.4 vs. 61.3 vs. 54.8 | 59.0 ± 15.1 vs. 58.1 ± 15.5 vs. 58.9 ± 15.1 | Low and average risk | Previous sphincterotomyActive pancreatitisCholangitisSepsisChronic pancreatitisFluid overload increased risk*PregnancyBalloon dilation of papillaPancreatic stent |
Ghaderi et al. (Iran, 2019) [33] | RCT (1:1), monocentre | 3.0 mL/(kg h) for 8 h after ERCP, bolus of 20 mL/kg after the procedure | Standard hydration [LR 1.5 mL/(kg h) during and for 8 h after ERCP, without bolus] | 120 aggressive hydration120 standard hydration | 51.6 vs. 52.5 | 51.57 ± 13.5 overall | Low and average risk | Previous sphincterotomyActive pancreatitisCholangitisSepsisChronic pancreatitisFluid overload increased risk*Electrolyte alterationsPregnancyAge > 70 yrs |
Guha et al. (India, 2023) [37] | RCT (1:1), monocentre | 3.0 mL/(kg h) for 8 h after ERCP, bolus of 20 mL/kg after the procedure | Indomethacin 100 mg endorectal | 178 aggressive hydration174 indomethacin | 69.9 vs. 71.3 | 44.0 ± 14.5 overall | Low and average risk | Active pancreatitisChronic pancreatitisFluid overload increased risk*Electrolyte alterationsPregnancyBreastfeedingAge > 70 yrsNSAIDs therapy in prior 7 days |
Chang et al. (Thailand, 2022) [35] | RCT (1:1), monocentre | 3,600 mL LR in 24 h starting 2 h before ERCP | Standard hydration | 100 aggressive hydration100 control group | 47 vs. 49 | 50.9 ± 10.6 vs. 50.4 ± 12.6 | Low and average risk | Active pancreatitisChronic pancreatitisFluid overload increased risk*Electrolyte alterationsPregnancyAge > 65 yrsPost-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