Investigations Into Sepsis-associated Acute Kidney Injury

Acute Kidney Injury Clinical Trial

Official title:

Investigations Into the Mechanisms for Bioenergetic Failure in Sepsis-associated Acute Kidney Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05694624
• Other study ID #: Record ID 3055
• Status: Recruiting
• 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
• 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:

-

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

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