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Catheter Outcomes With Sternotomy Cardiac Operated (STERNOCAT)

This study is currently recruiting participants.
Verified January 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborators:
Baxter Healthcare Corporation
WYM France
Abbott
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01648777
First received: July 20, 2012
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

Pneumonia occurs frequently in patients undergoing cardiac surgery and allows to increase their mortality. While chest physical therapy plays a crucial role to prevent postoperative pneumoniae, painful mobilization of the sternum after sternotomy limits chest physical therapy. The continuous local anesthetic infusion by multiperforated catheter decreases sternum pain. Because of this optimal pain management, early chest physical therapy could be more efficient and could contribute to decrease the rate of pneumonia.

The aim of this study is to test if management of sternotomy pain using continuous local anesthetic infusion by multiperforated catheter may contribute to decrease the rate of perioperative pneumonia.


Condition Intervention Phase
Pneumonia
Cardiac Surgery
Multiperforated Catheter
Analgesia
Critical Care Medicine
 Device: L bupivacaine
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cicatricial Analgesia Catheters Outcome on Bronchopulmonary Infection Number With Sternotomy Cardiac Operated

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Rate of post-operative pneumonia in hospital [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • all-cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • mechanical ventilation free days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • ICU free days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Rate of ICU readmission [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Reintubation rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Septic shock rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Extrarenal epuration rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Cerebral vascular injury rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Major Cardiac Adverse Events [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: March 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: L bupivacaine
Drug (L bupivacaine) and device (catheter) 750 patients undergoing cardiac surgery with sternotomy are treated with L-bupivacain in the multiperforated catheter of analgesia
 Device: L bupivacaine

L-bupivacain solution CHIROCAINE® 5mg/ml, flakon de 20 ml): for the intravenous bolus of 10 ml

o (CHIROCAINE®1.25mg/ml, 200 mL/unit, 400 ml in the accufusor infused at 8ml/h during 48h00: for infusion during 48h00

Other Name: catheter with L bupivacaine
Placebo Comparator: placebo
Isotonic Nacl 9°/00 solution 750 patients undergoing cardiac surgery with sternotomy are treated with isotonic NaCl solution (placebo) in the multiperforated catheter of analgesia
 Drug: placebo
  • Isotonic NaCl solution (9°/00) solution: for the intravenous bolus of 10 ml
  • Isotonic NaCl solution (9°/00) solution, 400 ml in the accufusor infused at 8ml/h during 48h00: for infusion during 48h00
Other Name: Isotonic NaCl solution

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • all patient more than 18 years old
  • planned cardiac surgery with sternotomy and bypass
  • Informed consent written

Exclusion criteria :

  • Refusal of patient to be included in the study
  • Age less than 18 years old
  • Pregnancy
  • Emergency
  • Prolonged sedation and ventilation more than 48h00 expected in teh postoperative period
  • Moribund patient
  • Palliative medicine
  • Patient in the care of a guardian
  • Preoperative pneumonia
  • Patient randomized in an other randomized study
  • Contraindication to L-bupivacain, morphine sulfate, paracetamol or tramadol
  • Lack of national health care insurance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01648777

Locations
France
Pitié salpetrière Hospital Recruiting
Paris, France, 75013
Contact: Julien Amour, MD, PhD     33 1 42 16 56 41     Julien.amour@psl.aphp.fr    
Principal Investigator: Julien Amour, MD, PhD            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Baxter Healthcare Corporation
WYM France
Abbott
Investigators
Principal Investigator: Julien Amour, MD, PhD APHP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01648777     History of Changes
Other Study ID Numbers: 2011-3289-10, A110903-48
Study First Received: July 20, 2012
Last Updated: January 25, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pneumonia
Postoperative infection
Cardiac surgery
Multiperforated catheter
Analgesia

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bupivacaine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013