Evaluating the Role of Cystatin C and Creatinine as Markers of Renal Recovery in Critically Ill Patients After Acute Kidney Injury.

Chronic Kidney Disease Clinical Trial

Official title:

Evaluating the Role of Cystatin C and Creatinine as Markers of Renal Recovery in Critically Ill Patients After Acute Kidney Injury.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894164
• Other study ID #: CysCr1
• Status: Completed
• Phase: N/A
• First received: September 5, 2016
• Last updated: August 22, 2017
• Start date: January 2008
• Est. completion date: December 2014

Study information

• Verified date: August 2017
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a cohort study in which patients who survive Acute Kidney Injury (AKI) during intensive care unit (ICU) admission are recalled at 3-6 months and renal function tests are performed.

The purpose of the study is describe renal function in AKI survivors at follow-up.

Additional aims are to determine how well admission values of renal function markers perform as predictors of renal function at follow-up and whether estimates of renal function at follow-up differ depending on which renal function marker is used.

Description:

Type of study: Cohort study with prospectively collected clinical data cross-matched with local & national databases.

Source population: Patients suffering from AKI on a mixed intensive care unit, at the Karolinska University Hospital, Solna.

Setting: Single centre, Central Intensive Care unit Karolinska University hospital, Solna, Stockholm from September 2008 and May 2011.

Exposure: AKI on ICU and grade of AKI according to the RIFLE criteria Intervention: none

Outcome: Renal function 3 months after ICU discharge according to creatinine and Cystatin C measurements.

Parameters: Co-morbidities, ICU diagnoses, disease severity score, daily physiological and laboratory parameters, medications administered, interventions RRT (Renal replacement therapy), mechanical intervention, inotropes, surgery.

Data is crossmatched with national registries including the Swedish cause of death register (to obtain dates of death), the Swedish renal register (to obtain details of patients receiving chronic dialysis and with pre-existing Chronic Kidney Disease (CKD) diagnoses. Data is also cross matched with a large local ICU register (Clinisoft) to obtain physiological parameters& intervention details. Clinisoft is also used to obtain risk of death for all ICU patients and all AKI patients (from the source population). Ethical approval has been granted by Stockholm Regional ethical review body (2008-408-32 2008/443-31/1-3, 2010/1780-31-2, 2011-408-32 and 2016-1801-32).

Aims:

1. Describe the incidence of renal dysfunction in terms of Glomerular filtration rate (GFR) under 60ml/min/173m² at 3-6 months follow-up after AKI. According to serum Cystatin C and Creatinine values.

2. Describe the incidence of Acute Kidney Disease (AKD) at 3 month follow-up.

3. Produce a predictive model using comorbidities and admission data to CKD (Chronic Kidney Disease) and AKD 3-6 after AKI in intensive care patients.

4. Examine how estimated GFR using creatinine and Cystatin C differ from measured Iohexol GFR at 6 month follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: December 2014
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Adults treated on Intensive care with AKI (RIFLE criteria)

• Survival 3 months after discharge.

• Admission during September 2008-May 2011

Exclusion Criteria:

• Under 18 years

• Unable to give consent.

• Admission during a time when study staff not working.

• Death before 3 month follow-up

• No Swedish personal identification number

Related Conditions & MeSH terms

• Acute Kidney Disease
• Acute Kidney Injury
• Chronic Kidney Disease
• Critical Illness
• Kidney Diseases
• Renal Insufficiency, Chronic
• Wounds and Injuries

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
Sweden	Karolinska Institute	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. Epub 2004 May 24. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function	Renal function as defined by estimated glomerular filtration rate (eGFR)using seri Creatinine and Cystatin C at follow-up	3-9 months
Secondary	Mortality	Death as recorded in the swedish national death register.	2 years