Investigations Into Sepsis-associated Acute Kidney Injury

NCT05694624 | Recruiting

• 1 other identifier: Record ID 3055
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Hemodynamics

  Systemic and regional hemodynamics

  Repeated measures at 10am, 12am, 2pm, 4pm,6pm, and 8pm

Secondary Outcomes (1)

• Metabolic alterations

  Repeated measures at 10am, 12am, 2pm, 4pm,6pm, and 8pm

Study Arms (2)

Sepsis patients

Patients admitted to the intensive care unit with sepsis diagnosed or suspected

Drug: Para Aminohippurate

Surgical patients

Previously healthy patients who are operated for colon cancer with laparoscopic technique.

Drug: Para Aminohippurate

Interventions

Para Aminohippurate DRUG

Measurements of renal plasma flow and glomerular filtration rate

Also known as: iohexol

Sepsis patients; Surgical patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Intensiv care patients Surgical patients

You may qualify if:

• 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

Sponsors & Collaborators

• University Hospital of North Norway: lead

Study Sites (1)

University Hospital of North Norway

Tromsø, Troms, 9038, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

p-Aminohippuric Acid; Iohexol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Aminohippuric Acids; Hippurates; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Keto Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Triiodobenzoic Acids; Iodobenzoates

Study Officials

• Lars MG Ytrebø

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars M Ytrebo, MD PhD

CONTACT

+4790788058; lars.marius.ytrebo@unn.no

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: January 23, 2023
• Study Start: August 14, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)