KDIGO Bundle to Prevent AKI in Sepsis

NCT ID: NCT04222361

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-31

Study Completion Date

2022-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Septic Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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KDIGO guide recommendations

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Standard care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital General Universitario Elche

OTHER

Sponsor Role lead

Responsible Party

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María Mercader Alarcón

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Surgical Intensive Care Unit of the General University Hospital of Elche

Elche, Alicante, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Maria Mercader Alarcon, MD, DESA

Role: CONTACT

+34696195678

Facility Contacts

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Ana Perez Carbonell, MD, PhD

Role: primary

+34605266485

Other Identifiers

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PI 42/2018

Identifier Type: -

Identifier Source: org_study_id

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