Catheter Outcomes With Sternotomy Cardiac Operated (STERNOCAT)
Primary Purpose
Pneumonia, Cardiac Surgery, Multiperforated Catheter
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
L bupivacaine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia focused on measuring Pneumonia, Postoperative infection, Cardiac surgery, Multiperforated catheter, Analgesia
Eligibility 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
Sites / Locations
- Pitié salpetrière Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
L bupivacaine
placebo
Arm Description
Drug (L bupivacaine) and device (catheter) 750 patients undergoing cardiac surgery with sternotomy are treated with L-bupivacain in the multiperforated catheter of analgesia
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
Outcomes
Primary Outcome Measures
Rate of post-operative pneumonia in hospital
Secondary Outcome Measures
all-cause mortality
mechanical ventilation free days
ICU free days
Hospital stay
Rate of ICU readmission
Reintubation rate
Septic shock rate
Extrarenal epuration rate
Cerebral vascular injury rate
Major Cardiac Adverse Events
Full Information
NCT ID
NCT01648777
First Posted
July 20, 2012
Last Updated
April 23, 2015
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Baxter Healthcare Corporation, WYM France, Abbott
1. Study Identification
Unique Protocol Identification Number
NCT01648777
Brief Title
Catheter Outcomes With Sternotomy Cardiac Operated
Acronym
STERNOCAT
Official Title
Cicatricial Analgesia Catheters Outcome on Bronchopulmonary Infection Number With Sternotomy Cardiac Operated
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Baxter Healthcare Corporation, WYM France, Abbott
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
Introduction:
Pneumonia occurs in 15 to 20% of patients undergoing cardiac surgery and allows to increase their mortality. Early non-invasive ventilation (NIV) after extubation and active and passive chest physical therapies have shown to diminish risk of respiratory failure and lowered 90-day mortality. Unfortunately, pain after cardiac surgery is mainly related to the median sternotomy. The mobilization of the sternum after sternotomy induces paroxysmal and periodical pain, sorely control by opioid treatment, regulated by the chest movements of ventilation or chest mobilization such during NIV or chest physical therapy. The continuous local anesthetic infusion by multiperforated catheter has been shown to be effective for decreasing paroxysmal sternum pain, opioid analgesic medication, length of intensive care medicine (ICU) and hospital stay. Because of this better pain management, early NIV and chest physical therapy could be more efficient and could contribute to decrease the rate of pneumonia in patients undergoing cardiac surgery with sternotomy.
Hypothesis: 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.
Primary end-point: Rate of post-operative pneumonia in hospital. Secondary end-points: post operative quality of Analgesia (total morphine consumption), 30-days all-cause mortality, mechanical ventilation free days, ICU free days, hospital stay, rate of ICU readmission, reintubation rate, septic shock rate, extrarenal epuration rate, cerebral vascular injury rate, Major Cardiac Adverse Events at 30-days, mortality at 30 days.
Method: This is a multicenter (5 french university centers) double blind randomized study compared to placebo. Patients are randomized the day before surgery (computer randomization) between L-bupivacaine and placebo which is infused with continuous local anesthetic infusion by multiperforated catheter at the end of cardiac surgery with sternotomy. Anesthesia protocol is pre-established (propofol and sufentanil with TCI and atracurium only at the induction), tranexamic acid (bolus of 20 mg/kg and 2mg/kg/h). Total dose of each agent is reported in the electronic case report (eCRF, cleanWeb®). Antibioprophylaxy is standardized in agreement with French guidelines in cardiac surgery. Analgesic treatment is standardized as well. During the first postoperative 48 hours: paracetamol (1g x4/day), morphine sulfate (intravenous titration and immediately after the end of titration, self pain management with morphine pump during 48 hours for all the patients included in the study. Total dose of morphine sulfate is reported in the eCRF. In addition, intravenous ketoprofen may be associated in addition if requested. Multiperforated catheter is introduced at the end of surgery above steel sternal bands. A bolus of 10 ml of L-bupivacain or placebo is infused into the catheter at the end of surgery when skin suture is done. Then, the elastomeric pump is connected to the catheter for 48 postoperative hours at 8ml/hour. Extubation is done ideally in the first 6 postoperative hours and chest kinesitherapy is performed at day 1 and 2, in postoperative period. Follow up is done during 30 days after surgery.
Statistical analysis: Rate of pneumonia is expected to be 18% in the placebo group, and 12.6% in the L-bupivacaine group. The number of patients needed (with alpha=0.05, beta= 0.80) is estimated to be 1500 patients (750 patients by group). Because 5 centers are expected to participate, 15% only of eligible patients in all these centers will be enough. Twenty four months would be necessary for the inclusion with 1 month more for the follow up. Thus, the study would last 25 months.
Ethical issue: The present study will be presented to pitie salpetriere Research Ethics Board for approval. An independent Safety Board will survey the study.
Conclusion: This study should decrease the rate of pneumonia in patients undergoing cardiac surgery with sternotomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Cardiac Surgery, Multiperforated Catheter, Analgesia, Critical Care Medicine
Keywords
Pneumonia, Postoperative infection, Cardiac surgery, Multiperforated catheter, Analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1502 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L bupivacaine
Arm Type
Experimental
Arm Description
Drug (L bupivacaine) and device (catheter) 750 patients undergoing cardiac surgery with sternotomy are treated with L-bupivacain in the multiperforated catheter of analgesia
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
L bupivacaine
Other Intervention Name(s)
catheter with L bupivacaine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Isotonic NaCl solution
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of post-operative pneumonia in hospital
Time Frame
30 days
Secondary Outcome Measure Information:
Title
all-cause mortality
Time Frame
30 days
Title
mechanical ventilation free days
Time Frame
30 days
Title
ICU free days
Time Frame
30 days
Title
Hospital stay
Time Frame
30 days
Title
Rate of ICU readmission
Time Frame
30 days
Title
Reintubation rate
Time Frame
30 days
Title
Septic shock rate
Time Frame
30 days
Title
Extrarenal epuration rate
Time Frame
30 days
Title
Cerebral vascular injury rate
Time Frame
30 days
Title
Major Cardiac Adverse Events
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien Amour, MD, PhD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pitié salpetrière Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
30617461
Citation
Amour J, Cholley B, Ouattara A, Longrois D, Leprince P, Fellahi JL, Riou B, Hariri S, Latremouille C, Remy A, Provenchere S, Carillion A, Achouh P, Labrousse L, Tran Dinh A, Ait Hamou N, Charfeddine A, Lafourcade A, Hajage D, Bougle A; STERNOCAT investigators. The effect of local anesthetic continuous wound infusion for the prevention of postoperative pneumonia after on-pump cardiac surgery with sternotomy: the STERNOCAT randomized clinical trial. Intensive Care Med. 2019 Jan;45(1):33-43. doi: 10.1007/s00134-018-5497-x. Epub 2019 Jan 7.
Results Reference
derived
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Catheter Outcomes With Sternotomy Cardiac Operated
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