CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 647 enrolled
Drug / intervention
Opioid based analgesia +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00673712
NCT00673712Phase 4Completed
CompareCT.gov

Phase 4 Multicenter Infection Surveillance Study Following Cardiac Surgical Procedures

Halyard Health·interventional·Posted May 7, 2008·Updated Jan 19, 2018

In Brief

A Phase 4 clinical trial evaluating Continuous Sternal Block and Opioid based analgesia for Surgery and 2 related conditions. Completed, enrolled 647 participants across 8 sites.

Detailed Summary

The main goals of the study are as follows: (1) to determine the correlation between pain management using continuous infusion of local anesthetics and the incidence of pneumonia and surgical infection in cardiac surgery patients; and (2) to evaluate the relationship between hospital-acquired pneumonia and surgical infection and patient outcomes, including length of hospital stay.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSurgery, Pneumonia, Surgical Site Infection
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 7, 2008
Enrollment StartApr 1, 2008
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 18.2 years ago

Interventions

Continuous Sternal Blockdevice

Elastomeric Pump for Continuous Infusion of Local Anesthetic

Opioid based analgesiadrug

Opioid Analgesic agents delivered by: PCA on demand mode IV injections PRN IM injections PRN Oral PRN