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Completed

NCT Number: NCT02821546

Aggressive Fluid Hydration for the Prevention of Post-ERCP Pancreatitis

Aggressive hydration with lactated Ringer's solution (LRS) has been shown in a preliminary research to reduce the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. This randomized, controlled trial was designed to assess the effect of peri-procedural aggressive intravenous hydration with LRS on the incidence of post ERCP pancreatitis.

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Key information

Conditions

Pancreatitis Digestive System Diseases Pancreatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Siriraj Hospital

Bangkok, 10700, Thailand

About this study

Patients underwent first-time ERCP were randomly assigned (1:1) to receive either LRS at a rate of 150 ml/hr starting 2 hours prior to procedure, and continued during and after procedure to complete 24 hours (aggressive hydration) or LRS at a rate calculated by the Holliday-Segar method given peri-procedurally as described earlier (standard hydration). Visual analog scale, serum amylase, lipase, C-reactive protein (CRP), and urine analysis were assessed prior to procedure and 24 hours after. The primary endpoint was post ERCP pancreatitis defined as new or increased epigastric pain persisting for ≥24 hours, elevation of amylase or lipase >3 times the upper limit of normal.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients at age between 18-65 years old undergoing first time ERCP

Exclusion criteria

  • Ongoing acute pancreatitis
  • Chronic pancreaittis
  • Prior sphincterotomy
  • Ongoing hypotension including those with sepsis
  • Cardiac insufficiency (CI, >NYHA Class II heart failure)
  • Renal insufficiency (RI, creatinine clearance <40mL/min)
  • Severe liver dysfunction (albumin < 3mg/dL)
  • Respiratory insufficiency (defined as oxygen saturation < 90%)
  • Pregnancy
  • Hyponatremia (Na+ levels < 130mEq/L))
  • Hypernatremia (Na+ levels > 150mEq/L)

Treatment and study plan

Lactated Ringer's solution

Drug

Standard fluid hydration with Lactated Ringer's solution is calculated based on Holiday Segar's equation Aggressive hydration with Lactated Ringer's solution is defined as administration of 150 ml/hour of fluid

Other names: Ringer's Lactated solution

Primary outcomes

  1. post ERCP pancreatitis

    Time frame: 24 hours

    Post ERCP pancreatitis is defined as hyperamylasemia (amylase >3 times the upper limit of normal [300 U/L]) and pancreatic pain (epigastric abdominal pain radiating to the back scored by patient as development of or increase of pain ≥3 on a 0-10 visual analogue pain scale and persisting for ≥24 hours after ERCP). In those who had pain before the procedure, pancreatic pain is defined as an increase of ≥3 on the 0-10 visual analogue scale.

Secondary outcomes

  1. severity of post ERCP pancreatitis

    Time frame: 24 hours

    severity is defined by length of hospital stay, mild pancreatitis is defined by hospitalization of 48 hours, moderate pancreatitis is defined by hospitalization of more than 48 hours without additional intervention, severe pancreatitis is defined by hospitalization of greater than 72 hours and/or requiring intervention

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 1, 2016
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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