Nephrologic Intervention in Patients Waiting for Cardiac Surgery

NCT02643745 | Completed

• 1 other identifier: AKIIQcor
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ACUTE KIDNEY INJURY

Keywords

acute kidney injury; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Change in Acute kidney injury stage defined using KDIGO (Kidney Disease Improving Global Outcomes) criteria

  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

  Day of surgery, 4 and 12 months

Secondary Outcomes (8)

• Mortality

  through study completion,up to 1 year

• Hospitalization days and length of stay in ICU

  1 month

• number of participants with Need of Renal Replacement Therapy

  1 month

• number of participants with Anemia and need of blood transfusion

  1, 4 and 12 months

• number of participants with Need of Use of inotropes after surgery

  The day of surgery

Study Arms (2)

Nephrology Intervention

EXPERIMENTAL

Nephrology intervention before surgery:

Procedure: Nephrology Intervention

Standard of Care

NO INTERVENTION

No nephrology intervention before surgery (standard of care)

Interventions

Nephrology Intervention PROCEDURE

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 if there is proteinuria * Start additional antihypertensive drug if required * Start hypolipemic treatment if required * Start hyperuricemia treatment if required * Start AAS, clopidogrel if it is necessary (prophylaxis) * Phosphate control * Anemia control * Metabolic acidosis correction

Nephrology Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Nephrology Department. Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (1)

• Codina S, Oliveras L, Ferreiro E, Rovira A, Coloma A, Lloberas N, Melilli E, Hueso M, Sbraga F, Boza E, Vazquez JM, Perez-Fernandez JL, Sabater J, Cruzado JM, Montero N. Nephrology intervention to avoid acute kidney injury in patients awaiting cardiac surgery: randomized clinical trial. Front Nephrol. 2024 Nov 13;4:1470926. doi: 10.3389/fneph.2024.1470926. eCollection 2024.

  PMID: 39606581 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Nuria Montero, MD

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: December 31, 2015
• Study Start: February 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: January 11, 2021

Record last verified: 2021-01

Locations

ES (1)