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

NCT ID: NCT02894164

Last Updated: 2017-08-23

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

COMPLETED

Total Enrollment

336 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Kidney Injury Chronic Kidney Disease Acute Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Claire Rimes-Stigare

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Max Bell, PhD

Role: STUDY_DIRECTOR

Karolinska Institutet

Johan MÃ¥rtensson, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Claes-Roland Martling, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska Institute

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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. doi: 10.1186/cc2872. Epub 2004 May 24.

Reference Type BACKGROUND
PMID: 15312219 (View on PubMed)

Other Identifiers

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CysCr1

Identifier Type: -

Identifier Source: org_study_id

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