Sepsis Clinical Trial - Kidney Response to Sepsis Affects Angiogenic

Status Active, not recruiting

Clinical Trial Summary

This study investigates the mechanism by which kidney dysfunction perpetuates inflammation, immunosuppression, and catabolism (PICS) in chronic critical illness. The investigators will test the hypothesis that persistent kidney dysfunction in sepsis associated by chronic critical illness contributes to decreased survival through the development of PICS. In chronic critical illness, the persistence of the inflammatory state may lead to capillary rarefication in the kidney causing accelerated chronic kidney disease. Progression of chronic kidney disease during chronic critical illness can drive PICS. Indeed, many of the features of chronic critical illness are consistent with the protein-energy malnutrition and muscle wasting associated with chronic kidney disease. Thus, the kidney can play a contributory role in chronic critical illness and PICS.

Clinical Trial Description

The main goal of this project is to measure kidney filtration function at day 14 or the day of discharge from hospital (whichever occurs first), in order to determine the presence and magnitude of persistent kidney dysfunction after sepsis episode and to longitudinally assess further decline of kidney function at one year follow-up. The measure of the glomerular filtration rate (GRF) in patients with chronic critical illness and controls (sepsis patients discharged from ICU before day 14) will be used to determine to what degree of kidney dysfunction contributes to decreased survival and increase in chronic kidney disease at year one after sepsis onset. One and/or all of the three ways for GFR assessment will be used, both at approximately day 14 or approximately at the day of discharge from the ICU and at the one year follow up : 1. Determine clearance of Iohexol from blood after Iohexol injection and/or 2. Determine apperance of Iohexol in urine after Iohexol injection (this would be the same injection as in one, and would not require two injections) and/or 3. A timed urine collection to determine clearance of urea and creatinine and/or 4. Estimated GFR using calculations with serum creatinine and cystatin C, This will provide an opportunity to validate the different measurements. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02276066
Study type	Interventional
Source	University of Florida
Contact
Status	Active, not recruiting
Phase	N/A
Start date	February 2015
Completion date	November 2022

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Kidney Response to Sepsis Affects Angiogenic Balance and Likelihood of CCI and PICS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms