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Not yet recruitingNCT05942846POLECATUpdated Jul 12, 2023

POLECAT: Perioperative Delta Renin Concentration

An observational study in Post Operative Vasoplegic Syndrome and Acute Kidney Injury, sponsored by Royal Surrey County Hospital NHS Foundation Trust. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-12.

Sponsored by Royal Surrey County Hospital NHS Foundation Trust · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
405
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Post Operative Vasoplegic Syndrome
  • Acute Kidney Injury
03

In context

Vasoplegia

48 studies on the registry are indexed under Vasoplegia; 19 are open to participants now.

This study's planned enrollment of 405 is above the median of 200 across 19 observational studies indexed under Vasoplegia.

Browse Vasoplegia studies →

Lead sponsor

Royal Surrey County Hospital NHS Foundation Trust is the lead sponsor of 35 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Planned and unplanned emergency general surgical procedures. All surgical patients who have an intensive care bed booked, will be screened.

To sample patients we will approach all patients who are booked to come to the ICU post operatively.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
405 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. • The difference between pre and post-operative levels of circulating renin, and association with vasoplegia.

    Time frame: 2 years

Secondary outcomes

  1. • Determine overall burden of vasopressor use post operatively.

    Time frame: 2 years

  2. • Incidence of post-operative AKI in this cohort of patients

    Time frame: 2 years

  3. • Trends of renin post-operatively following major abdominal surgery.

    Time frame: 2 years

  4. • Associations between changes in renin and AKI.

    Time frame: 2 years

  5. • Associations between type of surgery and incidence of post operative instability and renin measurements, with specific emphasis on patients with emergency surgery with peritonitis.

    Time frame: 2 years

  6. • Association between regular medications that alter the RAS-axis and changes in renin

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2023; primary completion for Jul 2025, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 4, 2023
First posted
Jul 12, 2023
StartEst.
Jul 2023
Primary completionEst.
Jul 2025
CompletionEst.
Jul 2025
Last update
Jul 12, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05942846
Lead sponsor
Royal Surrey County Hospital NHS Foundation Trust
Collaborators
European Society of Intensive Care Medicine
Responsible party
Sponsor
First posted
Jul 12, 2023
Start date
Jul 2023 (estimated)
Primary completion
Jul 2025 (estimated)
Completion
Jul 2025 (estimated)
Last update
Jul 12, 2023

Study contacts

Naomi Boyer, MBBS
Contact
n.boyer@nhs.net
01483571122
Syeda Fizza Haider, MBBS
Contact
syeda.haider1@nhs.net
01483571122
Lui Forni
principal investigator · Professor of Intensive Care Medicine, Royal Surrey Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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