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 |
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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 |
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 |
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Daptomycin (DAP)
DAP : Cohort of patients who received daptomycin as the first line treatment for at least 48 hours for the defined indication
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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
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Vancomycin (VAN)
VAN : Cohort of patients who received vancomycin as the first line treatment for at least 48 hours for the defined indication
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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
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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 |
Inclusion criteria:
Exclusion criteria:
France | |
Uh Montpellier | |
Montpellier, France, 34295 |
Principal Investigator: | Philippe Gaudard, MD | University Hospital, Montpellier |
Tracking Information | |||||
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First Submitted Date | May 16, 2019 | ||||
First Posted Date | May 23, 2019 | ||||
Last Update Posted Date | May 23, 2019 | ||||
Actual Study Start Date | January 1, 2016 | ||||
Actual Primary Completion Date | January 30, 2016 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Retrospective Analysis of Nephrotoxicity During Daptomycin Versus Vancomycin Treatments in High Risk Patients | ||||
Official Title | Acute Kidney Injury During Daptomycin Versus Vancomycin Treatment in Cardiovascular Critically Ill Patients: a Propensity Score Matched Analysis | ||||
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. |
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Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: None Retained Description:
Plasma: preoperative, ICU admission at POD0 and POD1 samples
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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 | ||||
Condition |
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Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
72 | ||||
Original Actual Enrollment | Same as current | ||||
Actual Study Completion Date | January 30, 2016 | ||||
Actual Primary Completion Date | January 30, 2016 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion criteria:
Exclusion criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03961503 | ||||
Other Study ID Numbers | Q-2015-05-03 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | University Hospital, Montpellier | ||||
Study Sponsor | University Hospital, Montpellier | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | University Hospital, Montpellier | ||||
Verification Date | May 2019 |