Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000167268
Ethics application status
Approved
Date submitted
4/01/2018
Date registered
2/02/2018
Date last updated
3/04/2024
Date data sharing statement initially provided
6/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Examining the effect of combined induced diuresis with euvolemic fluid resuscitation on contrast-induced nephropathy
Scientific title
Contrast-induced nephropathy in chronic kidney disease patients undergoing angiography and treatment with combined induced diuresis and euvolemic fluid resuscitation: a randomised controlled trial.
Secondary ID [1] 293670 0
None
Universal Trial Number (UTN)
Trial acronym
COINCIDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contrast-induced nephropathy 305964 0
Chronic kidney disease 305965 0
Condition category
Condition code
Renal and Urogenital 305159 305159 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prevention of contrast-induced nephropathy by combined induced diuresis with euvolemic fluid resuscitation.

All eligible participants will be approached by one of the study doctors to discuss their participation in the trial. They will be approached at their cardiology appointment or at the time their coronary angiogram is scheduled. At this time, they will be given a Participant Information Sheet and Consent Form, and all aspects of this document will be explained by the study doctor. Upon agreeing to participate in the trial, the participants are randomised on a 1:1 basis into either the control group or the experimental group.

The trial is being conducted at the Lyell McEwin Hospital, an acute tertiary care centre in the northern metropolitan suburbs of Adelaide. Every participant will be undergoing a coronary angiogram as a part of their care. The interventionalist performing their angiogram will be one of the study doctors. Once the participant has been randomised to one of the study groups, the study doctor will give instructions to the medical and nursing staff of the care and treatment that the participant will have. The study doctors are ultimately responsible for ensuring that the protocol is followed. The study doctors, PIs Pati and Arstall, and AI Mugwagwa, will prescribe the intervention or control treatment. Ward nursing staff will be responsible for continuing the administration of the treatment for the prescribed amount of time. Nursing staff will administer the medication for the intervention group as per the study doctors' instructions.

Dr Purendra Pati is the principal investigator for this trial. He is a consultant cardiology interventionalist and is coordinator of the cath-lab at the Lyell McEwin Hospital. He has extensive experience in managing patients with chronic kidney disease undergoing a coronary angiogram. A/Prof Margaret Arstall is also a principal investigator on this trial. She is the Director of Cardiology at the Northern Adelaide Local Health Network and has extensive experience as a consultant cardiologist and in research endeavours. Dr Augustine Mugwagwa is an associate investigator and study doctor on this trial. He is a cardiology advanced trainee and works under the direction and supervision of Dr Pati. Dr Nitesh Rao is also an associate investigator and study doctor on this trial. He is a consultant nephrologist who will provide expert advice to the other members of the study team in relation to kidney disease. Emily Aldridge is an associate investigator and study coordinator of this trial. She is a clinical researcher and is responsible for randomisation and data management.

The intervention is induced diuresis via furosemide and euvolemic fluid resuscitation. Participants in the intervention group will receive a dose of 0.5 mg/kg body weight of intravenous furosemide after a 250 ml bolus of normal saline. Urine output is measured hourly. The amount of fluid lost through urine output is replaced with intravenous saline until an output of > 300 ml is attained. If the participant fails to reach an output of > 300 ml, a repeat dose of furosemide and saline will be given.

The intervention occurs once only (unless a second dose is required as previously mentioned) and takes 1.5 - 3 hours. Once the desired output is reached, the study doctor performs the contrast procedure. After the procedure, the participant continues on matched hydration therapy for 12 hours. If the urine output falls below or fails to reach 150 ml/hr in the first four hours following the procedure, a repeat dose of furosemide will be given.
Intervention code [1] 299929 0
Prevention
Intervention code [2] 299930 0
Treatment: Drugs
Comparator / control treatment
The control group is treated with the current standard treatment for prevention of contrast-induced nephropathy. This involves having 24 hours of saline infusion: 12 hours prior to procedure, continuing during procedure, and continuing for 12 hours post-procedure. In the case of significant heart failure, the rate of fluid therapy will be tailored to avoid pulmonary oedema or fluid overload.
Control group
Active

Outcomes
Primary outcome [1] 304355 0
Binary outcome based on the proportion of participants who experienced CIN. CIN is defined as a more than or equal to 25% rise or absolute rise of more than or equal to 44 µmol/L in serum creatinine over the baseline value when measured in the 72 hours (+/- 12 hours) after contrast exposure.
Timepoint [1] 304355 0
Serum creatinine will be measured daily for at least three days following the procedure. If there is a rising trend of serum creatinine, then serum creatinine levels will continue to be followed up until the level stabilises or begins to fall. The primary timepoint will be the day 1 measurement.
Secondary outcome [1] 341715 0
Length of hospitalisation (days) assessed by data linkage to medical records and discharge summaries,
Timepoint [1] 341715 0
Number of consecutive days spent in hospital or hospital-at-home will be recorded once the participant has been discharged.

Eligibility
Key inclusion criteria
Inclusion criteria for this trial include:
1. All adult patients with advanced stage III, IV or V chronic kidney disease (serum creatinine more than 1.6 mg/dl (145 mmol/L) and eGFR of less than 40ml/min/1.73m2, and/or Mehran's risk score of 6-16) undergoing an elective or urgent, diagnostic or therapeutic radiocontrast procedure will be approached for consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for this trial include:
1. Patients with contrast allergy
2. Hypersensitivity to furosemide
3. Patient on maintenance haemodialysis or peritoneal dialysis
4. Radiocontrast procedure conducted within 72 hours
5. Contraindication or failure to pass urinary catheter
6. Patients with fluctuating baseline serum creatinine measurements
7. Patients with acute renal failure
8. Patients requiring emergency angiography procedures (e.g. STEMI cases)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2017
Date of last participant enrolment
Anticipated
Actual
3/04/2022
Date of last data collection
Anticipated
Actual
20/09/2022
Sample size
Target
166
Accrual to date
Final
166
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 298290 0
University
Name [1] 298290 0
University of Adelaide
Country [1] 298290 0
Australia
Primary sponsor type
Individual
Name
A/Prof Margaret Arstall
Address
Department of Cardiology
Level 1 Lyell McEwin Hospital
Haydown Road
Elizabeth Vale SA 5112
Country
Australia
Secondary sponsor category [1] 297698 0
None
Name [1] 297698 0
Address [1] 297698 0
Country [1] 297698 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299289 0
The Queen Elizabeth Hospital Human Research Ethics Committee
Ethics committee address [1] 299289 0
The Queen Elizabeth Hospital
Ethics: DX465101
Ground Floor, Basil Hetzel Institute
28 Woodville Road
WOODVILLE SOUTH SA 5011
Ethics committee country [1] 299289 0
Australia
Date submitted for ethics approval [1] 299289 0
13/04/2017
Approval date [1] 299289 0
23/05/2017
Ethics approval number [1] 299289 0

Summary
Brief summary
Contrast-induced nephropathy is a relatively common complication for chronic kidney disease patients who are undergoing a procedure involving contrast dye, such as a coronary angiogram, affecting around 15% of patients in this population. This condition is characterised by kidney damage that occurs a short time, usually within three days, after having the contrast procedure. We know when a patient experiences contrast-induced nephropathy by observing the levels of creatinine, an enzyme produced by the kidney, in the blood. Creatinine levels are observable from a blood test. Rates of contrast-induced nephropathy can likely be reduced using hydration and forced diuresis (increased urine output using medication). Currently, we try to reduce the incidence of contrast-induced nephropathy by hydrating patients with intravenous saline before and after the angiogram. However, it may be possible to reduce the rates of contrast-induced nephropathy even further by implementing a new regime of hydration and forced diuresis. This research project aims to identify a new, effective method of reducing rates of contrast-induced nephropathy in patients with advanced stage III, IV and V chronic kidney disease who are having a coronary angiogram at the Lyell McEwin Hospital. Patients who consent to participate in this research project will be randomly sorted in one of two groups: the control group (patients who will receive the current usual standard of care, which involves receiving saline through an intravenous drip) and the experimental group (patients who will receive a dose of furosemide for forced diuresis and euvolemic fluid replacement). Participants will not be randomised into a group until they have provided written informed consent agreeing to participate. The primary outcome for this study is development of contrast-induced nephropathy. The secondary outcomes is length of hospitalisation.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2311 2311 0 0
/AnzctrAttachments/374217-23 05 17 Protocol.docx (Protocol)
Attachments [2] 2312 2312 0 0
/AnzctrAttachments/374217-17 05 17 PICF Version 2.docx (Participant information/consent)
Attachments [3] 2313 2313 0 0
/AnzctrAttachments/374217-Approval Letter - Q20170403 - Pati.pdf (Ethics approval)

Contacts
Principal investigator
Name 79926 0
Dr Purendra Pati
Address 79926 0
Department of Cardiology
Level 2, Lyell McEwin Hospital
Haydown Road
Elizabeth Vale, South Australia, 5112
Country 79926 0
Australia
Phone 79926 0
+61456317481
Fax 79926 0
Email 79926 0
[email protected]
Contact person for public queries
Name 79927 0
Emily Aldridge
Address 79927 0
Robinson Research Institute
Level 2, Lyell McEwin Hospital
Haydown Road
Elizabeth Vale, South Australia, 5112
Country 79927 0
Australia
Phone 79927 0
+610881332134
Fax 79927 0
Email 79927 0
[email protected]
Contact person for scientific queries
Name 79928 0
Emily Aldridge
Address 79928 0
Robinson Research Institute
Level 2, Lyell McEwin Hospital
Haydown Road
Elizabeth Vale, South Australia, 5112
Country 79928 0
Australia
Phone 79928 0
+610881332134
Fax 79928 0
Email 79928 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics compliance


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.