Effectiveness and Safety of Danshen Injection for Acute Kidney Injury in Primary Nephrotic Syndrome
Condition: Acute Kidney Injury; Nephrotic Syndrome; Nephropathy
MeSH terms: Acute Kidney Injury; Nephrotic Syndrome; Nephrosis; Syndrome; Wounds and Injuries
Study type: Observational

Summary: 
      The goal of this real-world observational study is to evaluate the effectiveness and safety
      of the Chinese herbal-derived therapeutic Danshen injection following immunosuppressive
      therapy and prophylactic anticoagulation with low molecular heparin for acute kidney injury
      in primary nephrotic syndrome. The main questions to answer are:

      Whether or not Danshen injection is beneficial for acute kidney injury patients in primary
      nephrotic syndrome patients.

      Whether or not Danshen injection will increase the bleeding risk in primary nephrotic
      syndrome patients receiving low molecular heparin.

      Participants' information will be retrieved from hospital files stored in medical records and
      the electronic patient data registry. Participants received Danshen injection will be
      compared with control group to evaluate the recovery of renal function and side effects.
    

Detailed description: 
      Background and objectives： Acute kidney injury (AKI) is a common complication of primary
      nephrotic syndrome (PNS), affecting approximately 23.7% to 34% of PNS patients. No randomized
      clinical trials and clinical drug intervention studies focus on renal function recovery of
      AKI in PNS patients. The aim of this study is to assess the clinical effectiveness and safety
      of a common traditional Chinese herbal medicine (Danshen) in PNS with AKI patients.

      Methods:

      This study will be a retrospective cohort study of PNS with AKI patients. Renal function
      recovery and adverse events of the patients receiving Danshen injection(DS group) will be
      compared with that of the patients with supportive care(SC group) .The study will be
      conducted using Hospital Information System of the First Affiliated Hospital of Wenzhou
      Medical University which has longitudinal health information on over 6 million predominantly
      privately insured individuals and includes over 50 million followup records. The data of
      inpatients diagnosed with nephrotic syndrome will be reviewed retrospectively. Patients'
      information includes socio-demographic characteristics, administrative claims (diagnosis and
      procedure codes), medical histories, laboratory test results and pharmacy claims. PNS wih AKI
      inpatients will be enrolled. The baseline characteristics will be propensity-score matched.
      The outcomes are complete and partial renal function recovery for effectiveness analysis and
      severe bleeding events for safety analysis. Comparisons of cumulative recovery rate will be
      performed by Kaplan-Meier curves and log-rank test. Risks for outcomes will be assessed using
      Cox proportional hazard regression models.
    

Intervention name(s): Dandshen
Intervention type(s): Drug
Intervention description(s): Dandshen injection 20ml /day
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study will be conducted using Hospital Information System of the First Affiliated
        Hospital of Wenzhou Medical University which has longitudinal health information on over 6
        million predominantly privately insured individuals and includes over 50 million followup
        records. 3873 patients with nephrotic syndrome will be reviewed retrospectively. Patients'
        information includes socio-demographic characteristics, administrative claims (diagnosis
        and procedure codes), medical histories, laboratory test results and pharmacy claims.
      
Keywords: acute kidney injury; nephrotic syndrome; Danshen injection