KDIGO Bundle to Prevent AKI in Sepsis

NCT04222361 | Unknown

• 1 other identifier: PI 42/2018
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Summary: Controlled, prospective, randomized and randomized clinical trial of two intervention groups (standard care vs. preventive recommendations the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines for AKI) of patients diagnosed with sepsis and abdominal post-surgical septic shock with positive results in the risk determination of acute renal injury by NephroCheck® Test that integrates the urinary biomarkers TIMP-2 and IGFBP-7. Hypothesis: The implementation of a package of preventive measures proposed by the KDIGO guide can reduce the occurrence and severity of acute renal injury in the high-risk abdominal post-surgical septic patient detected by urinary biomarkers for early detection.

Conditions

Septic Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Compare the incidence of moderate-severe acute renal injury

  Compare the incidence of moderate-severe acute renal injury (stages KDIGO 2 and 3) in the first 72 hours of diagnosis of sepsis and septic post-surgical septic shock in patients at high risk of AKI determined by NephroCheck® Test (those with a ≥0.3 ng / ml2 / 1000 result) that the package of preventive measures proposed by the KDIGO guideline is applied vs. standard treatment

  72 hours

Secondary Outcomes (6)

• Compare mortality from any cause

  90 days

• Compare the number of participants in need of renal replacement therapy

  90 days

• Compare the number of participants with persistent renal dysfunction

  90 days

• Compare the number of days of stay in the Surgical ICU

  90 days

• Compare the number of days of stay in the hospital

  90 days

Study Arms (2)

KDIGO guide recommendations

EXPERIMENTAL

Preventive recommendations the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines for AKI

Procedure: Preventive recommendations for kidney disease: guidelines for improving overall outcomes (KDIGO) for AKI

Standard care

NO INTERVENTION

The patients assigned to the control group will receive the current standard care of the septic patients of the Unit according to our protocols

Interventions

Preventive recommendations for kidney disease: guidelines for improving overall outcomes (KDIGO) for AKI PROCEDURE

Patients assigned to the treatment group will receive the AKI preventive recommendations from the KDIGO guide: withdraw nephrotoxics, ensure volemia and renal perfusion pressure by means of advanced hemodynamic monitoring-optimization (minimum monitoring objective: Unit algorithm based on volume systolic (VS) by pulse wave analysis - Flotrac® / ClearSight® system - or transpulmonary thermodilution - VolumeView® system -), monitor plasma creatinine and urinary expenditure, avoid hyperglycemia (serum blood glucose target: 110-149 mg / dl), and consider alternatives to diagnostic-therapeutic radiocontrast procedures.

KDIGO guide recommendations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years.
• Patients (or their informed family members) who accept and sign the informed consent.
• Patients diagnosed with sepsis or abdominal post-surgical septic shock.

You may not qualify if:

• Patients under 18 years.
• Patients (or their authorized relatives) who refuse to sign the informed consent.
• Patients diagnosed with sepsis or non-surgical septic shock.
• Patients diagnosed with sepsis or septic shock of origin other than abdominal.
• Patients with AKI stages KDIGO 2 and 3 and / or renal replacement therapy.
• Patients with chronic renal failure and glomerular filtration \<30 ml / min and / or undergoing treatment with dialysis or previous renal transplantation.
• Patients with AKI of origin other than the diagnosed septic, such as glomerulonephritis or interstitial nephritis, renal artery occlusion and / or postrenal obstruction.

Sponsors & Collaborators

• Hospital General Universitario Elche: lead

Study Sites (1)

Surgical Intensive Care Unit of the General University Hospital of Elche

Elche, Alicante, 03203, Spain

RECRUITING

Central Study Contacts

Maria Mercader Alarcon, MD, DESA

CONTACT

+34696195678; mariamercader@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2020
• First Posted: January 10, 2020
• Study Start: October 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: November 1, 2022
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)