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

Completed

• Conditions: Infection Related to Vascular Prothesis; Infective Endocarditis; Infection Related to Ventricular Assist Device; Mediastinitis; Surgical Site Infection
• Interventions: Drug: Daptomycin (DAP) treatment; Drug: Vancomycin (VAN) treatment

• Registration Number: NCT03961503
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2016-01-30
• Study Completion: 2016-01-30
• Status Verified: 2019-05
• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-22
• Last Update Submitted: 2019-05-22
• Study First Posted: 2019-05-23
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Daptomycin (DAP)	Daptomycin (DAP) treatment	DAP : Cohort of patients who received daptomycin as the first line treatment for at least 48 hours for the defined indication
Vancomycin (VAN)	Vancomycin (VAN) treatment	VAN : Cohort of patients who received vancomycin as the first line treatment for at least 48 hours for the defined indication

Primary Outcome Measures

Name	Time	Method
Incidence of Acute Kidney Injury (AKI)	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

Name	Time	Method
Duration of RRT	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)
Incidence of clinical treatment failure	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
Incidence of Acute Kidney Injury (AKI)	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
Maximal decrease of glomerular filtration rate (GFR)	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
Incidence of renal replacement therapy (RRT)	Through study treatment completion, an average of 2 weeks	RRT initiated between the first and the last treatment administrations
Incidence of premature discontinuation of treatment	Through study treatment completion, an average of 2 weeks	defined as a treatment stopped because of adverse event or clinical failure except death
Incidence of severe renal failure	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
Mortality	6 months (180 days) after treatment initiation	all cause mortality

Trial Locations

Locations (1)

Uh Montpellier; 🇫🇷 Montpellier, France