Evolution Natriuretic Peptide Concentrations of B-type (BNP) During General Anesthesia Under Propofol and Sevoflurane Association in Patients Previously Sensitized to Anthracyclines (PEPNATB)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT01754597
First received: November 6, 2012
Last updated: July 25, 2013
Last verified: December 2012
  Purpose

The cardiotoxicity of anthracyclines chemotherapy remains a major problem, despite clinical and echocardiographic monitoring. In the case of treatment for breast cancer, surgery requiring general anesthesia may follow chemotherapy. Although a possible interaction between general anesthetics and anthracyclines on systolic function is only rarely mentioned, some cases of heart failure and / or conduction disturbances peranesthésique were observed in patients treated or previously treated with anthracyclines. The determination of concentration of BNP is a diagnostic tool used in the detection of heart failure and acute coronary syndromes. The question of a possible synergism between cardiotoxic anthracyclines and anesthetic agents arises. Given its minimally invasive nature and its diagnostic value, the BNP assay might thus allow to highlight a possible subclinical deficiency. To our knowledge, there is very little data regarding a possible synergism between cardiotoxic anthracyclines and anesthetic agents.


Condition Intervention
Breast Cancer
Drug: Peptide Natriurétique de type B

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evolution Natriuretic Peptide Concentrations of B-type (BNP) During General Anesthesia Under Propofol and Sevoflurane Association in Patients Previously Sensitized to Anthracyclines. Pilot Study in Patients Operated on for Breast Cancer. Monocentric Study Feasibility.

Resource links provided by NLM:


Further study details as provided by Institut Bergonié:

Primary Outcome Measures:
  • Describe the evolution of the concentrations of NT-proBNP, through repeated dosing during general anesthesia in patients operated on for breast cancer and anthracycline-sensitized or not [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Describe the evolution of the concentrations of NT-proBNP, through repeated dosing during general anesthesia in patients operated on for breast cancer and anthracycline-sensitized or not


Secondary Outcome Measures:
  • Depending on the sensitivity to anthracyclines, study the proportion of patients with subclinical heart failure in the general anesthesia during surgery for breast cancer [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    Depending on the sensitivity to anthracyclines, study the proportion of patients with subclinical heart failure in the general anesthesia during surgery for breast cancer

    • In patients treated with anthracyclines, highlight the factors associated (cumulative dose of anthracycline front, left breast radiotherapy) to subclinical heart failure
    • In patients treated with anthracyclines, assess describe the relationship between the dose of anthracycline received preoperative and percentage of maximum variation of the concentration of NT-proBNP in the first 24 hours after surgery


Enrollment: 56
Study Start Date: September 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peptide Natriurétique de type B
Peptide Natriurétique de type B
Drug: Peptide Natriurétique de type B
Peptide Natriurétique de type B

Detailed Description:

The cardiotoxicity of anthracyclines chemotherapy remains a major problem, despite clinical and echocardiographic monitoring. In the case of treatment for breast cancer, surgery requiring general anesthesia may follow chemotherapy. Although a possible interaction between general anesthetics and anthracyclines on systolic function is only rarely mentioned, some cases of heart failure and / or conduction disturbances peranesthésique were observed in patients treated or previously treated with anthracyclines. The determination of concentration of BNP is a diagnostic tool used in the detection of heart failure and acute coronary syndromes. In fact, it is one of the most sensitive markers of impaired myocardial function, and an increase in interest rates may precede any other biological changes. In a patient who received anthracycline, although it remains asymptomatic elevation of NT-proBNP concentration may persist for some months after exposure, and that, whatever the doses received. The question of a possible synergism between cardiotoxic anthracyclines and anesthetic agents arises. Given its minimally invasive nature and its diagnostic value, the BNP assay might thus allow to highlight a possible subclinical deficiency. To our knowledge, there is very little data regarding a possible synergism between cardiotoxic anthracyclines and anesthetic agents.

  Eligibility

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

Inclusion Criteria:

  • Women over 18 years with effective contraceptive method (if applicable)
  • NT-proBNP <125 pg / ml
  • ASA 1 or 2,
  • Breast cancer histologically proven
  • Mastectomy or lumpectomy
  • Neoadjuvant chemotherapy with anthracyclines in 6 months or received no chemotherapy with anthracyclines,
  • Patients who received the briefing and signed the informed consent
  • Patients affiliated to a social security system.

Exclusion Criteria:

  • Patients for whom the maintenance of general anesthesia does not use halogenated.
  • Renal impairment: Creatinine clearance <60 ml / min,
  • Patients who for reasons psychological, social, family or geographical could not be treated or monitored regularly according to the criteria of the study, patients deprived of liberty or under guardianship.
  • Presence of a cardiopathy
  • Pregnant Women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754597

Locations
France
Institut Bergonié
Bordeaux, Aquitaine, France, 33000
Sponsors and Collaborators
Institut Bergonié
Investigators
Study Chair: GEKIERE Jean Pierre, MD Institut Bergonié
  More Information

Additional Information:
No publications provided

Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT01754597     History of Changes
Other Study ID Numbers: IB2009-39
Study First Received: November 6, 2012
Last Updated: July 25, 2013
Health Authority: France: National Security Agency of Medicines and Health Products

Keywords provided by Institut Bergonié:
Patients with breast cancer requiring surgical management with general anesthesia

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anesthetics
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Anesthetics, General

ClinicalTrials.gov processed this record on September 16, 2014