Renin as a Biomarker of Haemodynamic Normalisation

NCT04303455 | Completed

• 1 other identifier: 2019/PID15341
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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. 1.admission to the Intensive Care Unit (ICU) after elective and emergency cardiac surgery using cardiopulmonary bypass
2. 2.age 18 years and above
3. 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

Conditions

Shock

Keywords

Biomarkers of shock; Biomarkers of adverse outcomes in shocked patients; Biomarkers of adverse outcomes in cardiothoracic patients

Outcome Measures

Primary Outcomes (1)

• Patterns of changes in serum renin concentrations are associated with composite morbidity at 30 days in participants who have undergone cardiac surgery.

  30 days

Secondary Outcomes (3)

• 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)

  24 hours

• Serum renin concentrations correlate with Pmsa in postoperative cardiac surgical patients

  24 hours

• Patterns of changes in serum renin concentrations are associated with AKI or the need for CRRT in participants who have undergone cardiac surgery

  30 days

Study Arms (1)

Study group

The study will evaluate a cohort of participants meeting the following 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 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

Diagnostic Test: blood sampling

Interventions

blood sampling DIAGNOSTIC_TEST

sampling serum renin

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Admission to ICU after elective and emergency cardiac surgery following cardiopulmonary bypass

You may qualify if:

• Admission to ICU after elective and emergency cardiac surgery following cardiopulmonary bypass
• Age 18 years and above
• Arterial, central venous catheters and pulmonary arterial catheters are inserted preoperatively

You may not qualify if:

• Age under 18 years
• Known pregnancy
• Arterial, central venous catheters and pulmonary arterial catheters that are not indicated as part of routine care
• End stage renal disease requiring renal replacement therapy
• Participants with known Child Pugh A cirrhosis or greater
• Treatment with any steroids
• Participant is not expected to live beyond the day after the day of admission

Sponsors & Collaborators

• South West Sydney Local Health District: lead

Study Sites (1)

Dr Wajid Khan

Sydney, New South Wales, 2170, Australia

Location

Related Publications (4)

• 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.

  PMID: 30407370 BACKGROUND

• Myles PS. Meaningful outcome measures in cardiac surgery. J Extra Corpor Technol. 2014 Mar;46(1):23-7.

  PMID: 24779115 BACKGROUND

• Hall A, Busse LW, Ostermann M. Angiotensin in Critical Care. Crit Care. 2018 Mar 20;22(1):69. doi: 10.1186/s13054-018-1995-z.

  PMID: 29558991 RESULT

• Khanna AK. Tissue Perfusion and Prognosis in the Critically Ill-Is Renin the New Lactate? Crit Care Med. 2019 Feb;47(2):288-290. doi: 10.1097/CCM.0000000000003582. No abstract available.

  PMID: 30653057 RESULT

MeSH Terms

Conditions

Shock

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 11, 2020
• Study Start: March 24, 2020
• Primary Completion: February 15, 2021
• Study Completion: March 12, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)