TIMP2*IGFBP7 and Transient AKI

NCT03472079 | Recruiting

• 1 other identifier: PI2018_843_0013
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with septic shock in the intensive care unit have a high risk to develop acute kidney injury (AKI) and AKI is an independent risk factor of mortality. Given the absence of validated pharmacological treatments for limiting the progression of AKI or for accelerating recovery from AKI, early intervention and the restoration of the glomerular filtration rate (GFR) in this context of septic shock might improve the patients' prognosis. One major challenge is to determine whether or not the AKI is reversible (return to normal function KDIGO 0 within 72 hours). In this retrospective study the investigators will analyze all patients admitted for a septic shock in three French ICUs between the 1st january 2014 and 01st January 2017 who developed an AKI (KDIGO ≥1) at admission and who had a determination of the urine concentration of TIMP2\*IGFBP7 at admission. The investigators will determine the best threshold of TIMP2\*IGFBP7 to distinguish the population of patients who will return to normal kidney function within 72 hours (KDIGO 0).

Conditions

Septic Shock

Keywords

Acute kidney injury; Septic shock; TIMP2*IGFBP7

Outcome Measures

Primary Outcomes (1)

• KDIGO value

  : Transient AKI defined by the return to KDIGO 0 within the first 72 hours following the introduction of catecholamines

  return to KDIGO 0 within the first 72 hours following the introduction of catecholamines

Secondary Outcomes (1)

• need for renal replacement therapy

  within the first 72 hours following the introduction of catecholamines

Eligibility Criteria

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

Study Population

univariate comparison between the 2 groups (transient and persistent AKI) using Mann Whithney test or Chi square test. ROC curve analysis to determine the best threshold of TIMP2\*IGFBP7 groups to distinguish the 2 groups.

You may qualify if:

• Age 18 or over

You may not qualify if:

• Need for immediate renal replacement therapy, anuria, chronic renal failure (stage 4 or 5 with GFR\<30ml/min), obstructive AKI, pregnancy, cardiac arrest during the same hospitalization, life expectancy\<48 hours, Child C Cirrhosis, prior occurrence of AKI during the current hospital stay, kidney transplantation.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80000, France

RECRUITING

MeSH Terms

Conditions

Shock, Septic; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Julien Maizel, Pr

CONTACT

+33 3 22 08 78 07; maizel.julien@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 21, 2018
• Study Start: May 1, 2017
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

FR (1)