NCT05105009CompletedPhase 1
Furosemide and Creatinine Tubular Stress Test in Order to Measure Proximal Tubule Residual Function
Furosemide and Creatinine Tubular Stress Test in Order to Measure Proximal Tubule Residual Function: is It Better Than GFR?
Source: ClinicalTrials.gov · Last updated 17 Dec 2024
Brief summary (registry, in English)
This is a two phase study. The first part will take place at the National Institute of Cardiology in Mexico, the second phase will be made in collaboration with the University of California San Diego and University of Minnesota. This is a non blind experimental study, 72 patients with different stages of CKD from the outpatient unit of the institute will be included. Each patient will receive a furosemide stress test of 1 mg/kg in non diuretic users and 1.5 mg/kg in diuretic users, in addition of 5 grams of creatinine oral intake, as well as Iohexol 5ml IV to measure GFR. After the intervention, blood and urine samples will be drawn at baseline, 60 minutes, 180 minutes, and 240 min. Urine output will be maintained during the study by the intravenous administration of Hartman's solution 1 -2 ml/kg body weight every hour, in addition to the volume of urine output in the preceding hour plus oral water ingestion as tolerated. Blood and urine will be analized to measure creatinine (blood and urine), then samples will be processed for measurement of furosemide (HPLC-Uv vis), indoxyl sulphate, p-cresol, hippurate, and iohexol (mass spectometry). The aim of this stiudy is to asses the differences between GFR and proximal tubule function.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 11 Mar 2020
- Start date
- 3 Mar 2020
- Primary completion date
- 21 Oct 2023
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Diseases
- Chronic kidney disease
- NCT number
- NCT05105009
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 50
- From 3 Mar 2020 to the primary completion date, 21 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with cardiorrenal syndrome type 1.
Lab values
- Increase of Cr in a rate of 0.5 mg/dL, or loss of more than 30% of previous GFR.
Age
- Patients younger than 18 years old.
Other
- Patients with dilated miocardiopathy.
- Volume overload or incomplete voiding
Who the study is looking for
- Patients older than 18 years old.
- Patients with CKD that attends to the outpatient clinic.
- Residual uresis of 500 mL
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Nacional de Cardiologia Ignacio Chavez Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.