POLECAT: Perioperative Delta Renin Concentration

NCT05942846 | Unknown

• 1 other identifier: 319836
• Study Type: observational
• Target: 405
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post Operative Vasoplegic Syndrome; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (6)

• • Determine overall burden of vasopressor use post operatively.

  2 years

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

  2 years

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

  2 years

• • Associations between changes in renin and AKI.

  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

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

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Surrey County Hospital NHS Foundation Trust: lead
• European Society of Intensive Care Medicine: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

• Ethylenediaminetetraacetic acid (EDTA) blood bottles will be centrifuged using a refrigerated centrifuge for 15 minutes to separate the plasma. . PAXGene for subsequent leukocyte transcriptomics analysis.

MeSH Terms

Conditions

Vasoplegia; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Lui Forni

  Professor of Intensive Care Medicine, Royal Surrey Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naomi Boyer, MBBS

CONTACT

01483571122; n.boyer@nhs.net

Syeda Fizza Haider, MBBS

CONTACT

01483571122; syeda.haider1@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 12, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 12, 2023

Record last verified: 2023-07