Acute Post-cardiac Surgery Renal Failure: Prevention Through Individualized Intensive Hemodynamic Management

NCT04005105 | Completed

• 1 other identifier: PrevHemAKI
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND: The incidence of acute kidney injury (AKI) in patients undergoing cardiac surgery can reach 35% and between 2 and 5% require kidney replacement therapy during the AKI episode. The development of AKI n this context is independently associated with higher long-term mortality (5-10 years). In addition, there is strong evidence that an episode of AKI in the hospital increases the risk of developing chronic kidney disease in the medium-long term. On the other hand, once AKI has been recovered according to creatinine values, there are no established biomarkers to predict patients at risk of progression to chronic kidney disease, which will allow us to increase nephroprotection and surveillance measures in this group of patients. STUDY DESIGN: Open-label randomized unicentric prospective study of patients undergoing valvular replacement heart surgery ± coronary bypass with acute kidney injury (AKI) risk \>30% according to the Leicester Cardiosurgery scale. Patients will be randomized 1:1 in two groups: standard hemodynamic management or intensive hemodynamic management based on premorbid mean perfusion pressure (MPP). The interventional period will span from intra-operation until the first 24 hours postoperative. The incidence of AKI will be evaluated according to KDIGO criteria between 48 hours and 7 days after surgery. Patients will be followed for one year. Biomarkers of mitochondrial damage will be analyzed at various points during the follow-up to patients presenting AKI. INTERVENTIONS: A) Group 1/Intensive management: Intra-surgical values of ± 25% basal MAP will be maintained and once in the ICU an algorithm corresponding to group 1 based on cardiac index and ± 25% MPP will be followed for 24 hours. B) Group 2/Standard management: MAP during surgery will be maintained \> 60 mmHg according to usual protocol. Once in ICU, during the first 24 hours an algorithm corresponding to group 2 based on cardiac index, MAP and CVP will be followed. Biomarkers of mitochondrial damage will be determined in urine in patients in both groups only in patients developing AKI according to KDIGO guidelines between 48h and 7 days. EXPECTED RESULTS:A 50% reduction in the incidence of AKI in the intervention group compared to the control group is expected. At the same time, markers of mitochondrial damage are expected to be validated in our cohort as biomarkers of AKI progression and to investigate its usefulness as biomarkers of transition to Chronic kidney disease.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• AKI incidence

  Reduction in the incidence of AKI

  18 months

Secondary Outcomes (2)

• Major kidney adverse events (MAKE) at 30, 90, 365 days

  12 months

• ICU and hospital length of stay

  18 months

Study Arms (2)

Intensive management

ACTIVE COMPARATOR

Baseline mean blood pressure (MAP) and central venous pressure (CVP) will be measured to calculate baseline mean perfusion pressure. Intra-surgical values of ± 25% basal MAP will be maintained and once in the ICU an algorithm corresponding to group 1 based on cardiac index and MPP will be followed for 24 hours.

Behavioral: Intensive management

Standard management

NO INTERVENTION

MAP during surgery will be maintained \> 60 mmHg according to usual protocol. Once in ICU, during the first 24 hours an algorithm corresponding to group 2 based on cardiac index, MAP and CVP will be followed.

Interventions

Intensive management BEHAVIORAL

Management based on premorbid MAP and MPP

Intensive management

Eligibility Criteria

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

You may qualify if:

• Patients undergoing elective or urgent heart surgery with extracorporeal circulation at the Hospital Clínic de Barcelona.
• Valve and/or aortocoronary bypass surgery
• Risk of AKI \>30% according to the Leicester Cardiosurgery scale

You may not qualify if:

• End-stage kidney disease stage V
• Patients with AKI in the 7 days prior to surgery
• Interstitial glomerulonephritis or vasculitis
• Pregnancy
• Kidney transplant
• Endocarditis
• Patients with mechanical assistance devices (ECMO, LVAD, RVAD, IABP)
• Emergence surgery
• Patients in need of pressure-directed therapy of cerebral infusion.
• Constrictive pericarditis

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Institut d'Investigacions Biomèdiques August Pi i Sunyer: collaborator
• Hospital Sant Joan de Deu: collaborator

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

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

• Esteban Poch, PhD, MD

  Hospital Clinic of Barcelona

  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: Head of the Department of Nephrology and Kidney Transplantation

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 2, 2019
• Study Start: October 14, 2019
• Primary Completion: October 1, 2022
• Study Completion: September 1, 2023
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)