Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04303455




Registration number
NCT04303455
Ethics application status
Date submitted
8/03/2020
Date registered
11/03/2020
Date last updated
24/03/2021

Titles & IDs
Public title
Renin as a Biomarker of Haemodynamic Normalisation
Scientific title
Renin as a Biomarker of Haemodynamic Normalisation: Associations With Outcomes After Cardiac Surgery
Secondary ID [1] 0 0
2019/PID15341
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shock 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - blood sampling

Study group - The study will evaluate a cohort of participants meeting the following inclusion criteria:
Admission to ICU after elective and emergency cardiac surgery following cardiopulmonary bypass
Age 18 years and above
Arterial, central venous and pulmonary arterial catheters have been inserted as part of routine care
Data collection, serum renin among routine blood collection on admission, 6 and 24 hours after admission to ICU


Diagnosis / Prognosis: blood sampling
sampling serum renin
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patterns of changes in serum renin concentrations are associated with composite morbidity at 30 days in participants who have undergone cardiac surgery.
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
Patterns of changes in serum renin concentrations correlate with current markers of resuscitation in participants who have undergone cardiac surgery ( C.I, SvO2, MAP, urine output, serum lactate, based deficit, venoarterial CO2 gradients)
Timepoint [1] 0 0
24 hours
Secondary outcome [2] 0 0
Serum renin concentrations correlate with Pmsa in postoperative cardiac surgical patients
Timepoint [2] 0 0
24 hours
Secondary outcome [3] 0 0
Patterns of changes in serum renin concentrations are associated with AKI or the need for CRRT in participants who have undergone cardiac surgery
Timepoint [3] 0 0
30 days

Eligibility
Key inclusion criteria
1. Admission to ICU after elective and emergency cardiac surgery following
cardiopulmonary bypass

2. Age 18 years and above

3. Arterial, central venous catheters and pulmonary arterial catheters are inserted
preoperatively
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age under 18 years

2. Known pregnancy

3. Arterial, central venous catheters and pulmonary arterial catheters that are not
indicated as part of routine care

4. End stage renal disease requiring renal replacement therapy

5. Participants with known Child Pugh A cirrhosis or greater

6. Treatment with any steroids

7. Participant is not expected to live beyond the day after the day of admission

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/03/2021
Sample size
Target
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Dr Wajid Khan - Sydney
Recruitment postcode(s) [1] 0 0
2170 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
South West Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Study design Observational, single centre, prospective cohort study Planned sample size 100
participants

Inclusion criteria The study will evaluate a cohort of participants meeting the following
inclusion criteria:

1. admission to the Intensive Care Unit (ICU) after elective and emergency cardiac surgery
using cardiopulmonary bypass

2. age 18 years and above

3. arterial, central venous and pulmonary arterial catheters have been inserted as part of
routine care Study procedures In addition to routine clinical postoperative data and
blood collection, serum renin levels will be analysed on admission, 6 and 24 hours after
admission to ICU Study duration 6 months
Trial website
https://clinicaltrials.gov/ct2/show/NCT04303455
Trial related presentations / publications
Nguyen M, Denimal D, Dargent A, Guinot PG, Duvillard L, Quenot JP, Bouhemad B. Plasma Renin Concentration is Associated With Hemodynamic Deficiency and Adverse Renal Outcome in Septic Shock. Shock. 2019 Oct;52(4):e22-e30. doi: 10.1097/SHK.0000000000001285.
Myles PS. Meaningful outcome measures in cardiac surgery. J Extra Corpor Technol. 2014 Mar;46(1):23-7.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04303455