Post Operative Vasoplegic SyndromePOLECATNCT05942846
POLECAT: Perioperative Delta Renin Concentration
An observational study of Post Operative Vasoplegic Syndrome and Acute Kidney Injury, run by Royal Surrey County Hospital NHS Foundation Trust.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Vasoplegic Syndrome, Acute Kidney Injury
- How many people
- 405 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Medical subject headings
- Vasoplegia, Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
• The difference between pre and post-operative levels of circulating renin, and association with vasoplegia.
Measured: 2 years
Secondary outcomes (6)
• Determine overall burden of vasopressor use post operatively.
Measured: 2 years
• Incidence of post-operative AKI in this cohort of patients
Measured: 2 years
• Trends of renin post-operatively following major abdominal surgery.
Measured: 2 years
• Associations between changes in renin and AKI.
Measured: 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.
Measured: 2 years
• Association between regular medications that alter the RAS-axis and changes in renin
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study startJul 2023 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Vasoplegic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 405 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Responsible party
- Sponsor
- Investigators
- Lui Forni, Principal investigator, Professor of Intensive Care Medicine, Royal Surrey Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942846
- Sponsor's protocol ID
- 319836
- Acronym
- POLECAT
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POLECAT: Perioperative Delta Renin Concentration
- ClinicalTrials.gov ID
- NCT05942846
- Acronym / sponsor ID
- POLECAT / 319836
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 405 participants (estimated)
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
• The difference between pre and post-operative levels of circulating renin, and association with vasoplegia.
Time frame: 2 years
6 secondary outcomes
• Determine overall burden of vasopressor use post operatively.
Time frame: 2 years
• Incidence of post-operative AKI in this cohort of patients
Time frame: 2 years
• Trends of renin post-operatively following major abdominal surgery.
Time frame: 2 years
• Associations between changes in renin and AKI.
Time frame: 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.
Time frame: 2 years
• Association between regular medications that alter the RAS-axis and changes in renin
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lui Forni principal investigator
Professor of Intensive Care Medicine, Royal Surrey Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Vasoplegic Syndrome and Acute Kidney Injury, run by Royal Surrey County Hospital NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naomi Boyer, MBBS (01483571122, n.boyer@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• The difference between pre and post-operative levels of circulating renin, and association with vasoplegia. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.