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Nephrologic Intervention in Patients Waiting for Cardiac Surgery (AKIIcor)

This study is currently recruiting participants.
Verified January 2016 by Nuria Montero, Hospital Universitari de Bellvitge
Sponsor:
ClinicalTrials.gov Identifier:
NCT02643745
First Posted: December 31, 2015
Last Update Posted: January 5, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Nuria Montero, Hospital Universitari de Bellvitge
  Purpose

Acute kidney injury (AKI) is a frequent complication after cardiac surgery. Its incidence ranges from 19 to 44% depending on the study and which definition is used: Acute Kidney Injury Network (AKIN) classification or RIFLE criteria (Risk, Injury, Failure, Loss, End-Stage Kidney Disease) based on serum creatinine and urine output.

AKI is associated with increased mortality, more complications, a longer stay in the intensive care unit and hospital, and increased health care costs. Moreover, the patients who require renal replacement therapy (RRT) have the highest mortality and complications1.The mortality risk in patients developing acute renal dysfunction after cardiac surgery increases by approximately 40%, while the overall mortality rate after cardiac surgery ranges between 2% and 8%.

There are some well-known risk factors associated with AKI, including baseline patient characteristics (age and comorbidities), need of perioperative blood transfusion or presence of previous chronic kidney disease. The main objective of this study is to evaluate if a nephrologist management and control of potential risk factors of renal disease can be used to prevent AKI, thereby minimizing the risk of need RRT, reducing costs and improving survival in this patients.


Condition Intervention
ACUTE KIDNEY INJURY Procedure: Nephrology Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Nephrologic Intervention in Patients Waiting for Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Nuria Montero, Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • Change in Acute kidney injury stage defined using KDIGO (Kidney Disease Improving Global Outcomes) criteria [ Time Frame: Day of surgery, 4 and 12 months ]
    rise in serum creatinine ≥26.5 μmol/L in 48 h, or rise 1.5-1.9 times from baseline or Urine output of 0.5 mL/kg/h for 6-12 h


Secondary Outcome Measures:
  • Mortality [ Time Frame: through study completion,up to 1 year ]
    Mortality

  • Hospitalization days and length of stay in ICU [ Time Frame: 1 month ]
    Hospitalization days and length of stay in ICU

  • number of participants with Need of Renal Replacement Therapy [ Time Frame: 1 month ]
    Need of Renal Replacement Therapy

  • number of participants with Anemia and need of blood transfusion [ Time Frame: 1, 4 and 12 months ]
    Anemia and need of blood transfusion

  • number of participants with Need of Use of inotropes after surgery [ Time Frame: The day of surgery ]
    Use of inotropes after surgery (number, type, dose)

  • number of participants with Metabolic complications [ Time Frame: 4 and 12 months ]
    Diabetes mellitus, hypertension, dyslipidemia after discharge and hyperuricemia

  • Estimated glomerular filtration rate [ Time Frame: Each day of the hospitalization, 4 and 12 months ]
    Estimated glomerular filtration rate by CKD-EPI formulae

  • number of participants with Inflammation adverse events [ Time Frame: through study completion, up to 1 year ]
    Reactive C Protein value


Estimated Enrollment: 1100
Study Start Date: February 2015
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nephrology Intervention
Nephrology intervention before surgery:
Procedure: Nephrology Intervention
  1. pre-operative study:

    • Kidney function: creatinine, Glomerular filtration rate (GFR) and presence albuminuria or proteinuria. Assessment whether there is a functional component added.
    • Discard presence of renal disease: renovascular disease, glomerular disease, toxic, etc.
  2. optimise the patient' s overall condition with a pre-operative strategy:

    • Obesity control
    • Control protein, caloric, salt intake
    • Stop smoking
    • Good glycemic control
    • Start ACEI/ARA II (enalapril, ramipril, valsartan, losartan) if there is proteinuria
    • Start additional antihypertensive drug if required (amlodipine, manidipine, doxazosine, enalapril, ramipril, valsartan, losartan, hidralazine, bisoprolol)
    • Start hypolipemic treatment if required (atorvastatine, simvastatine, ezetimibe)
    • Start hyperuricemia treatment if required (alopurinol, febuxostate)
    • Start AAS, clopidogrel if it is necessary (prophylaxis)
    • Phosphate control
    • Anemia control
    • Metabolic acidosis correction
No Intervention: Standard of Care
No nephrology intervention before surgery (standard of care)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age >18 years
  • patients undergoing scheduled cardiac surgery
  • Informed consent

Exclusion Criteria:

  • a requirement for RRT before surgery
  • current outpatient management by a nephrologist or estimated GFR < 45 mL/min/1.73m2 estimated by CKD-EPI equation)
  • participating in another clinical trial
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02643745


Contacts
Contact: Nuria Montero, MD +34 93 260 73 85 n.montero@bellvitgehospital.cat
Contact: Josep M Cruzado, MD, PhD +34 93 260 76 02 jmcruzado@bellvitgehospital.cat

Locations
Spain
Nephrology Department. Hospital Universitari de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Nuria Montero, MD    0034932607385    n.montero@bellvitgehospital.cat   
Contact: Josep M Cruzado, MD    0034932607602    jmcruzado@bellvitgehospital.cat   
Sponsors and Collaborators
Hospital Universitari de Bellvitge
  More Information

Responsible Party: Nuria Montero, Dr., Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT02643745     History of Changes
Other Study ID Numbers: AKIIQcor
First Submitted: March 25, 2015
First Posted: December 31, 2015
Last Update Posted: January 5, 2016
Last Verified: January 2016

Keywords provided by Nuria Montero, Hospital Universitari de Bellvitge:
acute kidney injury
cardiac surgery

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases