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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05694624
Other study ID # Record ID 3055
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 14, 2023
Est. completion date December 31, 2024

Study information

Verified date July 2023
Source University Hospital of North Norway
Contact Lars M Ytrebo, MD PhD
Phone +4790788058
Email lars.marius.ytrebo@unn.no
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

In this study the investigators would like to study systemic and regional disturbances in patients with sepsis-associated acute kidney injury and in healthy controls undergoing laparoscopic abdominal surgery. Specifically study metabolic, hemodynamic and oxygen transport variables.


Description:

Acute kidney injury (AKI) in patients with sepsis has a very poor prognosis with up to 60% mortality. The pathobiology remains to be fully understood. Creatine and phosphocreatine, products of arginine metabolism through L-arginine:glycine amidinotransferase (AGAT) and its sister enzyme guanidinoacetate N-methyl-transferase (GAMT), provide an energy-buffering system that is essential for intracellular adenosine triphosphate (ATP) supply. We hypothesized that sepsis associated AKI may be caused by failure of this energy-buffering system. In series of pilot studies, we explored metabolic and bioenergetic patterns in patients and animals with high risk of developing AKI. These data suggest that sepsis associated AKI may be caused by failure of this alternative renal energy source. In the current application we propose a clinical investigation of renal metabolism and renal bioenergetics in patients with high and low risk of developing sepsis associated AKI. The primary objective is to directly investigate renal AGAT activity through the arginyl metabolites homoarginine, guanidino acetate, and creatine. Secondary objectives are to study renal and systemic hemodynamics, renal oxygenation, glomerular filtration rate (GFR), renal tubular function, and mitochondrial respiration.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria sepsis group: - Sepsis diagnosed or suspected - Normal premorbid serum creatinine measured or anticipated (if data are not available) - Normovolemia as indicated by a pulse pressure variation less than 12% Comparator group - Previously healthy individuals scheduled for laparoscopic colon cancer resection - Normal creatinine levels within 3 months before admittance to hospital. - Patients admitted to the intensive care unit with sepsis diagnosed or suspected - Previously healthy patients listed for elective colon cancer surgery Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Para Aminohippurate
Measurements of renal plasma flow and glomerular filtration rate

Locations

Country Name City State
Norway University Hospital of North Norway Tromsø Troms

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hemodynamics Systemic and regional hemodynamics Repeated measures at 10am, 12am, 2pm, 4pm,6pm, and 8pm
Secondary Metabolic alterations Renal arginine metabolism Repeated measures at 10am, 12am, 2pm, 4pm,6pm, and 8pm
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