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POLECAT: Perioperative Delta Renin Concentration

POLECAT: Perioperative Delta Renin Concentration

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05942846
Acronym
POLECAT
Enrollment
405
Registered
2023-07-12
Start date
2023-07-31
Completion date
2025-07-31
Last updated
2023-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Post Operative Vasoplegic Syndrome

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

European Society of Intensive Care Medicine
CollaboratorOTHER
Royal Surrey County Hospital NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
• The difference between pre and post-operative levels of circulating renin, and association with vasoplegia.2 years

Secondary

MeasureTime frame
• Incidence of post-operative AKI in this cohort of patients2 years
• Trends of renin post-operatively following major abdominal surgery.2 years
• Determine overall burden of vasopressor use post operatively.2 years
• 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
• Association between regular medications that alter the RAS-axis and changes in renin2 years
• Associations between changes in renin and AKI.2 years

Contacts

Primary ContactNaomi Boyer, MBBS
n.boyer@nhs.net01483571122
Backup ContactSyeda Fizza Haider, MBBS
syeda.haider1@nhs.net01483571122

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026