Lansoprazole Preventing Gastroduodenal Stress Ulcerations
Information source: Temple University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Patients Undergoing Elective Coronary Artery Bypass Graft
Intervention: Lansoprazole (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Temple University Official(s) and/or principal investigator(s):
Robert S Fisher, MD, Principal Investigator, Affiliation: Temple University
Summary
The primary objective of this study is to determine whether lansoprazole, administered
intravenously, can protect patients undergoing cardiac surgery from the development of and/or
progression of previously undetected acid/peptic disorders (erosive esophagitis, gastric
ulcer, duodenal ulcer, diffuse gastritis, duodenitis) as measured by the Lanza score and LA
classification for esophageal injury.
The secondary objectives of this study are:
1. To determine if intravenous lansoprazole protects against the development of clinically
important gastrointestinal bleeding in this population (overt bleeding or requiring
blood transfusion).
2. To determine if intravenous lansoprazole maintains the intragastric pH above that for
placebo throughout the study period.
Clinical Details
Official title: A Prospective, Randomized, Double-Blind Protocol to Compare the Efficacy of Lansoprazole to Ranitidine in Healing Pre-Existing and/or Preventing the Development of Gastroduodenal Stress Ulceration and Postoperative Bleeding in Patients Undergoing Elective Coronary Artery Bypass Graft or Cardiac Valve Replacement Surgery
Study design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Mucosal Erosions
Secondary outcome: Blood loss
Detailed description:
This is a randomized, double-blind single center study which compares the efficacy of
lansoprazole by IV infusion daily (60 mg bolus followed by 6 mg per hour) compared to
ranitidine 50 mg IV q12 h in healing pre-existing and preventing perioperative stress ulcers
and associated upper GI bleeding.
Patients will undergo a complete history including a medication history for intake of
ASA/NSAIDs/anticoagulants/antiplatelet agents, physical examination, complete blood count,
complete metabolic profile, ECG's and chest x-rays which rule out an exclusionary illness.
Female subjects will have a urine pregnancy test performed. They will then sign an informed
consent to participate in this randomized, double-blind study protocol. Patients will be
excluded if they are currently using acid suppressive therapy or if they have a history of
gastric/duodenal ulcers or gastroesophageal reflux disease that has required acid suppressive
therapy.
Patients will be randomized to receive either lansoprazole or ranitidine intravenously by
continuous intravenous infusion on the morning of surgery and on each of the subsequent 4
days. Computer randomization will be used with the code kept by pharmacy. The allocation
will be concealed. Medication will be delivered in a sealed, unlabeled container from the
pharmacy. Patients will be stratified between placebo and lansoprazole by preceding
ASA/NSAID use. Lansoprazole will be given as a 60 mg bolus preoperatively followed by 6 mg
per hour throughout the duration of the study. At the time of airway intubation in the
operating room for the surgery, a nasogastric tube with a built-in intragastric pH electrode
(Zinetics, Inc) will be passed into the mid-stomach by the anesthesiologist in place of the
standard nasogastric tube. Intragastric pH will be measured during the perisurgical period
until the morning of postoperative day 4, 72 hours after surgery. At that time, the
nasogastric tube/pH probe will be removed and patients will undergo
esophagogastroduodenoscopy (EGD) under sedation with midazolam and fentanyl. During the
endoscopy, the maximum number of submucosal hemorrhages and erosions in an endoscopic field
from the anterior and posterior walls of the antrum will be counted. Modified Lanza scores
for both the stomach and the duodenum will be determined to quantify gastric and duodenal
erosions and ulcerations6. We will also determine the LA classification of esophageal injury
and inflammation. Before removal of the endoscope, a wireless pH capsule (Bravo pH capsule;
Medtronic, Inc) will be placed in the body of the stomach 12 cm below the squamocolumnar
junction for an additional two day measurement of intragastric pH or until the time of
discharge from the hospital if less than 48 hours from the EGD. Thus, intragastric pH will
be monitored from the morning that the patient undergoes surgery for 6 days or until the time
of discharge.
After completion of surgery, all patients will be followed with hemoglobin and hematocrit
every 12 hours; all stools will be tested for blood qualitatively (Hemoccult) and
quantitatively (Hemaquant). Postoperatively, hemoglobin level will be maintained at or above
10 gm% using packed red blood cell transfusions as needed. Transfusion requirements will be
quantified. The times at which patients resume oral intake will be noted along with specific
data on oral liquid and solid food composition.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Patients with symptomatic coronary artery disease or valvular heart disease who require
corrective cardiac surgery will be eligible to participate in this study.
Inclusion Criteria:
- Patients undergoing cardiovascular surgery, specifically elective coronary artery
bypass graft or cardiac valve replacement surgery, at Temple University Hospital
- Able to provide informed consent
Exclusion Criteria:
- Evidence of active gastrointestinal bleeding
- Prior gastric (e. g. Billroth II) or esophageal surgery
- Pregnancy
- Pre-existing or current condition requiring acid-suppressive therapy - e. g. reflux
esophagitis, gastric or duodenal ulcer
- Current use of acid-suppressive therapy, such as proton pump inhibitors or histamine
type 2 receptor antagonists
- Contraindication to naso- or oro-gastric intubation (e. g. Zenker's diverticulum,
esophageal stricture)
- Bleeding diathesis
- Allergy to lansoprazole
- Advanced renal disease (BUN>40 and/or creatinine>2. 0.
- Advanced liver disease (Alkaline phosphatase, ALT, AST>2 x normal)
Locations and Contacts
Temple University School of Medicine, Philadelphia, Pennsylvania 19140, United States
Additional Information
Starting date: September 2005
Ending date: January 2006
Last updated: January 2, 2008
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