Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000116022
Ethics application status
Approved
Date submitted
28/01/2010
Date registered
3/02/2010
Date last updated
19/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Augmented Renal Clearance in The Intensive Care Unit - A Multicenter Study
Scientific title
An observation study of creatinine clearance in patients admitted to the intensive care unit for a duration greater than twenty-four hours.
Secondary ID [1] 1366 0
Nil
Universal Trial Number (UTN)
Trial acronym
ARCTICUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 256703 0
Condition category
Condition code
Infection 256856 256856 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 256857 256857 0 0
Other inflammatory or immune system disorders
Injuries and Accidents 256858 256858 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
a) Eight Hour Creatinine Clearance measures
b) Collection of Demographic Data and Illness Severity Scores
c) Collection of Haemodynamic variables
d) Record of ICU and Hospital Outcome

Data will be collected on a daily basis during the entire stay in the intensive care unit (ICU).
Intervention code [1] 255936 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257728 0
The primary outcome is the incidence of augmented renal clearance (ARC) in patients admitted to the ICU. Daily 8-hour creatinine clearance measures will be used to identify this, with figures > 160ml/min/1.73m2 and > 150ml/min/1.73m2 in young men and women respectively indicating ARC.

These measures are obtained by collecting the patients urine (by means of an indwelling urinary catheter) over an 8-hour period. A blood sample is drawn during this period, and the creatinine concentration is then estimated in both urine and blood.

The creatinine clearance is then calculated as: urinary creatinine concentration x urinary volume / plasma creatinine concentration, giving a figure in ml/min. This is then adjusted using the patients body surface area to a standard figure of 1.73m2 (to allow comparison between patients).
Timepoint [1] 257728 0
Daily until discharge from the ICU
Secondary outcome [1] 263089 0
Haemodynamic variables - such as mean arterial pressure, central venous pressure, heart rate and cardiac output. These will be obtained from bed-side monitors routinely used in the ICU.
Timepoint [1] 263089 0
Daily (at 0800hrs) until ICU discharge
Secondary outcome [2] 263152 0
Fluid Balance (measure of the net input and output of fluids in a given patient). This will be obtained from bedside records.
Timepoint [2] 263152 0
Daily (at 0800hrs) until ICU discharge
Secondary outcome [3] 263153 0
Inotrope use and dose. These are medications that are routinely prescribed to patients in order to improve cardiovascular performance. The dose and record of administration will be obtained from the bed-side medication chart.
Timepoint [3] 263153 0
Daily (at 0800hrs) until ICU discharge
Secondary outcome [4] 263154 0
ICU and Hosptial Outcome - This will involve determining whether the patient survived to ICU and hospital discharge or died. This will be obtained from the medical record.
Timepoint [4] 263154 0
At ICU and hospital discharge
Secondary outcome [5] 263155 0
APACHE II Scores on admission (Acute Physiology and Chronic Health Evaluation Score) - This is an illness severity score based on the patients pre-morbid conditions and physiological variables in the first 24hours of admission. This data will obtained from the medical chart and observation record.
Timepoint [5] 263155 0
During the first 24hours of ICU admission
Secondary outcome [6] 263156 0
SOFA scores - Sequential Organ Failure Assessment Scores. This score quantifies organ dysfunction in 6 key domains - Cardiovascular, Respiratory, Neurological, Haemopoietic, Hepatic and Renal. The scores are used to follow changes with treatment. Information from the medical chart and observations are used to calculate the scores.
Timepoint [6] 263156 0
Daily (0800hrs) until ICU discharge

Eligibility
Key inclusion criteria
Any patient requiring admission to the ICU with:
a) Expected length of stay (LOS) > 24hours
b) Normal renal function (admission serum creatinine < 120 umol/L)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1)Absence of invasive haemodynamic monitoring as a part of routine management
2) Absence of an indwelling urinary catheter (IDC) as a part of routine management
3) Evidence of renal impairment
4) 'At Risk' of acute kidney injury (AKI) (> 1.5 fold increase in Serum Creatinine from baseline or urine output (UO) < 0.5ml/kg/hr for > 6hrs prior to enrolment
5) Age < 18years
6) Pregnancy
7) Lack of informed consent
8) Rhabdomyolysis is suspected clinically or serum creatinine kinase > 5000
9) Clinician considers the patient is unsuitable for enrolment

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2010
Actual
5/04/2010
Date of last participant enrolment
Anticipated
Actual
16/02/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
281
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment outside Australia
Country [1] 2449 0
Singapore
State/province [1] 2449 0
Singapore
Country [2] 5426 0
Hong Kong
State/province [2] 5426 0
Shantin, NT
Country [3] 5427 0
Portugal
State/province [3] 5427 0
Coimbra

Funding & Sponsors
Funding source category [1] 256430 0
Hospital
Name [1] 256430 0
Royal Brisbane and Womens Hospital
Country [1] 256430 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Womens Hospital
Address
Butterfield Street, Herston
Queensland, 4029
Country
Australia
Secondary sponsor category [1] 255734 0
None
Name [1] 255734 0
Address [1] 255734 0
Country [1] 255734 0
Other collaborator category [1] 1091 0
Hospital
Name [1] 1091 0
Changi General Hospital
Address [1] 1091 0
2 Simei Street 3
Singapore, 529889
Country [1] 1091 0
Singapore
Other collaborator category [2] 277623 0
Hospital
Name [2] 277623 0
Prince of Wales Hospital
Address [2] 277623 0
Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Prince of Wales Hospital 30-32 Ngan Shing Street, Shantin, New Territories, Hong Kong SAR
Country [2] 277623 0
Hong Kong
Other collaborator category [3] 277624 0
Hospital
Name [3] 277624 0
Coimbra University Hospital
Address [3] 277624 0
Servico de Medicina Intensiva, Hospitais da Universidade de Coimbra, EPE Praceta Prof. Mota Pinto, Av. Bissaya Barreto 3000-075, Coimbra, Portugal
Country [3] 277624 0
Portugal

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258486 0
Royal Brisbane and Womens Hospital, Human Research Ethics Committee
Ethics committee address [1] 258486 0
Royal Brisbane and Womens Hospital
Butterfield Street
Herston, Brisbane, Queensland
4029
Ethics committee country [1] 258486 0
Australia
Date submitted for ethics approval [1] 258486 0
Approval date [1] 258486 0
03/08/2009
Ethics approval number [1] 258486 0
HREC/09/QRBW/192

Summary
Brief summary
The kidneys have a range of essential functions in the body. Central to their role in the excretion of waste products and pharmaceuticals is the filtration of plasma (the non-cellular component of blood). During this process, substances (such as glucose, amino acids, electrolytes, waste products and some drugs) leave the circulation and
enter the renal tubule. Subsequently, drugs / metabolites can be added to or reabsorbed from the filtrate as it passes along the tubule prior to excretion in the urine. In this manner the kidney is responsible for the elimination of a wide range of drugs and toxins.
The rate at which plasma is filtered by the kidneys is referred to as the glomerular filtration rate (GFR) and is largely determined by renal blood blow (RBF). Ideal filtration markers (substances that are only filtered and neither secreted nor reabsorbed by the kidneys) are used to accurately measure GFR (eg Sinistrin), although are not routinely
available in a clinical setting. Creatinine is a small molecular weight amino acid derivative that is freely filtered and secreted (10%) by the kidneys. A clinically useful measure of GFR involves calculating a timed creatinine clearance, which reflects the rate at which plasma is cleared of creatinine over a given period of time.

Although research has largely focused on patients with declining renal function, there has been little attention on those with augmented renal clearances (ARC). We believe this phenomenon is likely to be common in patients on admission to the intensive care unit, and to date, has been largely under appreciated, although the implications are significant.

For example, more rapid excretion of antibiotics may result in sub therapeutic levels, treatment failure or the selection of resistant micro-organisms. These complications in turn could significantly impact on morbidity and mortality associated with the patients ICU stay. This study will investigate this phenomenon in a population considered “at risk”, and define the role of commonly employed therapeutic inventions in promoting augmented clearances. This research will lead to further prospective work on tailoring dosage regimens in patients admitted to the ICU.
Trial website
Nil
Trial related presentations / publications
Pending
Public notes

Contacts
Principal investigator
Name 30782 0
Dr Andrew Udy
Address 30782 0
Royal Brisbane and Womens Hospital, Butterfield Street, Herston, Queensland, 4029
Country 30782 0
Australia
Phone 30782 0
+617364681111
Fax 30782 0
Email 30782 0
[email protected]
Contact person for public queries
Name 14029 0
Dr Dr. Andrew Udy
Address 14029 0
C/- Department of Intensive Care Medicine
Royal Brisbane and Womens Hospital
Butterfield Street, Herston, Brisbane
4029, Queensland
Country 14029 0
Australia
Phone 14029 0
+61 7 36368111
Fax 14029 0
Email 14029 0
[email protected]
Contact person for scientific queries
Name 4957 0
Dr Dr. Andrew Udy
Address 4957 0
C/- Department of Intensive Care Medicine
Royal Brisbane and Womens Hospital
Butterfield Street, Herston, Brisbane
4029, Queensland
Country 4957 0
Australia
Phone 4957 0
+61 7 36368111
Fax 4957 0
Email 4957 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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