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
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.
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.
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 →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.
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.
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Exclusion Criteria:
• The difference between pre and post-operative levels of circulating renin, and association with vasoplegia.
Time frame: 2 years
• 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
No study locations are listed for this record.
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.
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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Royal Surrey County Hospital NHS Foundation Trust