Follow-up of Long-term Renal Function After Acute Kidney Injury in ICU

Quality of Life Clinical Trial

— SURIA  

Official title:

A Study on the Follow-up of Long-term Renal Function After Acute Kidney Injury in ICU

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03302624
• Other study ID #: CHU-351
• Status: Recruiting
• Phase: N/A
• First received: October 2, 2017
• Last updated: October 5, 2017
• Start date: September 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: October 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 0473751195
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Acute kidney injury (AKI) involves poor prognosis in ICU patients. The renal prognosis at long term is unknown.

The study will determine chronic kidney injury incidence and quality of life, five years after AK during ICU stay.

Description:

Prospective study. All patients who participated ELVIS study (clinical trials: 00875069) can be enrolled in SURIA.

Patients are contacted by telephone. Investigator delivery objective and honest information. If patients accepts the study, answers will be collected.

Collected data are: creatinine serum, two surveys (quality of life and activities of daily living), date of onset of renal replacement therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 506
• Est. completion date: December 31, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

ICU Patients included in ELVIS study, AKI requiring renal replacement therapy Length of ICU stay = 48h

Exclusion Criteria:

Pregnant or nursing woman's job

Related Conditions & MeSH terms

• Acute Kidney Injuries
• Acute Kidney Injury
• Chronic Kidney Disease
• Kidney Diseases
• Quality of Life
• Renal Insufficiency, Chronic
• Renal Replacement Therapy
• Wounds and Injuries

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of chronic kidney disease	incidence of chronic kidney disease in patients who had an acute kidney injury during their ICU stay and requiring an renal replacement therapy	5 years after the first acute kidney injury requiring renal replacement therapy
Secondary	severity of CKD according to the International Classification of Chronic Kidney Disease	Kidney function will be measured by creatinine serum or chronic dialysis or kidney transplantation	5 years after the first acute kidney injury requiring renal replacement therapy
Secondary	impact of the renal replacement therapy on long-term renal function	Intermittent or continuous renal replacement therapy. Data collected in the database from ELVIS study. Kidney function will be measured by creatinine serum or chronic dialysis	5 years after the first acute kidney injury requiring renal replacement therapy
Secondary	quality of life	Quality of life will be assessed with the Q5D score	5 years after the first acute kidney injury requiring renal replacement therapy
Secondary	Activities of daily living	Activities of daily living will be assessed with the Katz adjustment scales	5 years after the first acute kidney injury requiring renal replacement therapy
Secondary	Mortality	Mortality	5 years after the first acute kidney injury requiring renal replacement therapy