Study Results
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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UNKNOWN
NA
100 participants
INTERVENTIONAL
2020-10-31
2022-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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KDIGO guide recommendations
Preventive recommendations the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines for AKI
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.
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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 (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.
18 Years
ALL
Yes
Sponsors
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Hospital General Universitario Elche
OTHER
Responsible Party
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María Mercader Alarcón
Principal Investigator
Locations
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Surgical Intensive Care Unit of the General University Hospital of Elche
Elche, Alicante, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PI 42/2018
Identifier Type: -
Identifier Source: org_study_id
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