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Trial record 70 of 528 for:    VANCOMYCIN

Retrospective Analysis of Nephrotoxicity During Daptomycin Versus Vancomycin Treatments in High Risk Patients (DVN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03961503
Recruitment Status : Completed
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

Acute kidney injury (AKI) is a frequent complication that occurs in 15 to 25% of patients after vascular surgery, and up to 40% of patients after cardiac surgery. AKI compromises seriously short and long-term prognosis of critically ill patients. Several AKI risk factors have been identified including a chronic pathology of the patient such as kidney failure or diabetes, acute kidney injury related to hemodynamic disorders during surgery, including cardiopulmonary bypass, or sepsis, and the use of nephrotoxic agents such as some antibiotics, colloids or iodine contrast agents. Avoiding nephrotoxic agents is therefore strongly recommended in ICU patients, to reduce the incidence of AKI, or to reduce its severity.

The aim of this cohort study was to assess whether the use of daptomycin, was associated to a lower incidence of AKI than vancomycin in cardiovascular ICU patients, with similar efficacy.

This is a retrospective observational study with a propensity score adjustment to reduce the bias of selection for a comparative analysis between two antibacterial treatments used in routine care.

Since treatments were not randomized, the investigators used the propensity score method for primary endpoint analysis. For this, the investigators included the covariates potentially related to treatment and outcome in a multivariate logistic model explaining the choice of treatment. This propensity score was used in the second model as an adjustment covariate included in the multivariate analysis to determine factors independently associated with the primary endpoint (AKI within 7 days).

The main hypothesis is the first line antibiotic treatment with daptomycin leads to less nephrotoxicity than vancomycin in a population known at high risk for AKI and with at least a similar efficacy on clinical success rate.

Condition or disease Intervention/treatment
Infective Endocarditis Infection Related to Ventricular Assist Device Infection Related to Vascular Prothesis Surgical Site Infection Mediastinitis Drug: Daptomycin (DAP) treatment Drug: Vancomycin (VAN) treatment

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Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Acute Kidney Injury During Daptomycin Versus Vancomycin Treatment in Cardiovascular Critically Ill Patients: a Propensity Score Matched Analysis
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : January 30, 2016
Actual Study Completion Date : January 30, 2016

Group/Cohort Intervention/treatment
Daptomycin (DAP)
DAP : Cohort of patients who received daptomycin as the first line treatment for at least 48 hours for the defined indication
Drug: Daptomycin (DAP) treatment
Group DAP : Daptomycin was administered at a dose of 8 mg/kg in thirty-minutes intravenous infusion every 24 hours in patients without severe impairment of kidney function or every 48 hours in case of GFR below 30 ml/min/m2. The creatine-kinase (CK) level was measured before the initiation of DAP and at least once a week to assess the occurrence of muscular toxicity defined by an increase of CK up to 3-fold the upper superior limit without any evidence of member ischaemia.
Other Name: Group DAP

Vancomycin (VAN)
VAN : Cohort of patients who received vancomycin as the first line treatment for at least 48 hours for the defined indication
Drug: Vancomycin (VAN) treatment
Group VAN : Vancomycin intravenous treatment was initiated by a loading dose of 30 mg/kg in 1 hour and followed by a continuous maintenance infusion dosing between 15 and 30 mg/kg/d. The VAN dose was adapted to achieve a target serum vancomycin steady-state concentration of 20-30 mg/L assessed by a daily pharmacologic monitoring (therapeutic drug monitoring).
Other Name: Group VAN

Primary Outcome Measures :
  1. Incidence of Acute Kidney Injury (AKI) [ Time Frame: 7 days after the treatment initiation ]
    AKI stade 1, 2 or 3 according to KDIGO definition with baseline creatinine given by the last creatinine value before the start of treatment

Secondary Outcome Measures :
  1. Incidence of Acute Kidney Injury (AKI) [ Time Frame: 14 days after the treatment initiation ]
    AKI stade 1, 2 or 3 according to KDIGO definition with baseline creatinine given by the last creatinine value before the start of treatment

  2. Maximal decrease of glomerular filtration rate (GFR) [ Time Frame: Through study treatment completion, an average of 2 weeks ]
    Decrease of GFR, estimated by CKD-EPI formula, from baseline as measured by all serum creatinine determinations during treatment

  3. Incidence of severe renal failure [ Time Frame: Through study treatment completion, an average of 2 weeks ]
    AKI stade 2 or 3 according to KDIGO definition or decrease of GFR more than 50% from baseline

  4. Incidence of renal replacement therapy (RRT) [ Time Frame: Through study treatment completion, an average of 2 weeks ]
    RRT initiated between the first and the last treatment administrations

  5. Duration of RRT [ Time Frame: Through study completion limited to ICU stay, an average of 2 weeks ]
    Number of days between the first RRT initiation and the end of the last RRT during the ICU stay (excluding RRT performed in a dialysis center for chronic renal failure)

  6. Incidence of clinical treatment failure [ Time Frame: 15 days after the end of treatment ]
    defined by either persistent positive cultures, worsening of clinical status, death due to initial infection, or relapse after the end of treatment. It was assessed in case of documented GPC infection

  7. Incidence of premature discontinuation of treatment [ Time Frame: Through study treatment completion, an average of 2 weeks ]
    defined as a treatment stopped because of adverse event or clinical failure except death

  8. Mortality [ Time Frame: 28 days after treatment initiation ]
    all cause mortality

  9. Mortality [ Time Frame: 6 months (180 days) after treatment initiation ]
    all cause mortality

Biospecimen Retention:   None Retained
Plasma: preoperative, ICU admission at POD0 and POD1 samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient admitted in Intensive Care Unit before and/or after cardiovascular surgery with at least one organ failure

Inclusion criteria:

  • Patient older than 18 years
  • Admitted in ICU from January 2010 to December 2012
  • Suspected or proven cardiac, vascular or profound surgical site infection with Gram-positive cocci (GPC) methicillin-resistant (MR) strains (including probabilistic treatment for patients with acquisition of MR risk factors)
  • Treatment duration greater than or equal to 48 hours (at least 2 doses of daptomycin administered or 2 days of vancomycin infusion)
  • Antibiotic treatment started in peri-operative (from 48 hours before the onset of surgery) or in postoperative period (during ICU stay)

Exclusion criteria:

  • Prophylaxis indication of antibiotics
  • Kidney disease on chronic dialysis
  • Acute onset of RRT before initiation of DAP or VAN treatment
  • Staphylococcus pneumonia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03961503

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Uh Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
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Principal Investigator: Philippe Gaudard, MD University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier Identifier: NCT03961503     History of Changes
Other Study ID Numbers: Q-2015-05-03
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Acute Kidney Injury
Infective Endocarditis
Foreign Body Associated Infection
Cardiovascular surgery
Additional relevant MeSH terms:
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Communicable Diseases
Surgical Wound Infection
Endocarditis, Bacterial
Wound Infection
Postoperative Complications
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Mediastinal Diseases
Thoracic Diseases
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents