NCT00220909

Brief 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. 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. 2.To determine if intravenous lansoprazole maintains the intragastric pH above that for placebo throughout the study period.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

January 11, 2008

Status Verified

January 1, 2008

First QC Date

September 20, 2005

Last Update Submit

January 2, 2008

Conditions

Patients Undergoing Elective Coronary Artery Bypass Graft

Keywords

Gastric erosionsProton pump inhibitors

Outcome Measures

Primary Outcomes (1)

  • Mucosal Erosions

Secondary Outcomes (1)

  • Blood loss

Interventions

LansoprazoleDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing cardiovascular surgery, specifically elective coronary artery bypass graft or cardiac valve replacement surgery, at Temple University Hospital
  • Able to provide informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University School of Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Interventions

Lansoprazole

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Robert S Fisher, MD

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

September 1, 2005

Study Completion

January 1, 2006

Last Updated

January 11, 2008

Record last verified: 2008-01

Locations

US(1)