Investigations Into Sepsis-associated Acute Kidney Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Para Aminohippurate.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigations Into the Mechanisms for Bioenergetic Failure in Sepsis-associated Acute Kidney Injury
Overview
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.
Detailed 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.
Interventions
- Drug Para Aminohippurate
Measurements of renal plasma flow and glomerular filtration rate
Primary outcome measures
- Hemodynamics [Time frame: Repeated measures at 10am, 12am, 2pm, 4pm,6pm, and 8pm]
Secondary outcome measures (1)
- Metabolic alterations [Time frame: Repeated measures at 10am, 12am, 2pm, 4pm,6pm, and 8pm]
Eligibility criteria
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
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Norway · 1 center
- University Hospital of North Norway — Tromsø
Identifiers
NCT: NCT05694624 · Record ID 3055