POLECAT: Perioperative Delta Renin Concentration

Acute Kidney Injury Clinical Trial

— POLECAT  

Official title:

POLECAT: Perioperative Delta Renin Concentration

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05942846
• Other study ID #: 319836
• Status: Not yet recruiting
• Start date: July 2023
• Est. completion date: July 2025

Study information

• Verified date: July 2023
• Source: Royal Surrey County Hospital NHS Foundation Trust
• Contact: Naomi Boyer, MBBS
• Phone: 01483571122
• Email: n.boyer[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

We want to measure the amount of a hormone called renin in people's bodies before and after they have major abdominal surgery. We want to see if changes in renin levels are connected to problems with blood flow, unstable blood pressure, and kidney damage after surgery.

Description:

The renin-angiotensin system (RAS) plays a key role in haemodynamic stability, vascular tone and electrolyte homeostasis. It is recognised that this system is dysfunctional during critical illness. It remains unknown as to whether significant dysfunction of RAS is found in patients who have undergone major abdominal surgery - however over 50% of these patients often require blood pressure support post-operatively, with nearly half of these patients having unexplained drops in blood pressure.

Renin represents an attractive biomarker that could be implicated in post operative vasoplegia and post operative AKI and as such elevated renin concentrations could be used to identify high-risk patients for cardiovascular instability and AKI who would benefit from timely intervention that could improve their outcomes, this would include the use of selective vasopressor agents such as angiotensin II which has been shown to confer a benefit in patients with underlying dysregulation of the RAS.

If we show that higher differences in renin concentrations are associated with a greater incidence of vasoplegia then we can design a subsequent clinical trial with a different treatment in those who have a higher change in renin. Such a trial is currently recruiting in Germany for patients with higher changes in renin due to cardiac surgery.

The primary aim is to assess whether there is an association between higher differences in renin concentrations (a protein that can be measured in your blood) and haemodynamic instability manifest as vasoplegia (patients exhibiting low blood pressure) in patients undergoing major abdominal surgery requiring post-operative admission to ICU.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 405
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• All patients having abdominopelvic surgery (planned or unplanned) needing ICU admission where arterial line or central line will been placed

• Able to provide consent, or personal/professional agreement

Exclusion Criteria:

• Patient < 18 years old at time of screening

• Patients already receiving vasopressor support pre-operatively

• Receiving palliative care at the time of recruitment or expected to die within next 24 hours

• Those on kidney replacement therapy (KRT) or end stage kidney disease (ESKD)

• Patient or consultee unable to communicate in verbal and written English

• Patients held in an institution by legal or official order

• Patients with severe mental health disorders that might impair their capacity

Related Conditions & MeSH terms

• Acute Kidney Injury
• Vasoplegia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Royal Surrey County Hospital NHS Foundation Trust	European Society of Intensive Care Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• The difference between pre and post-operative levels of circulating renin, and association with vasoplegia.		2 years
Secondary	• Determine overall burden of vasopressor use post operatively.		2 years
Secondary	• Incidence of post-operative AKI in this cohort of patients		2 years
Secondary	• Trends of renin post-operatively following major abdominal surgery.		2 years
Secondary	• Associations between changes in renin and AKI.		2 years
Secondary	• Associations between type of surgery and incidence of post operative instability and renin measurements, with specific emphasis on patients with emergency surgery with peritonitis.		2 years
Secondary	• Association between regular medications that alter the RAS-axis and changes in renin		2 years