Kidney Response to Sepsis Affects Angiogenic Balance and Likelihood of CCI and PICS
June 13, 2024 updated by: University of Florida
Persistent Inflammation, Immunosuppression and Catabolism Syndrome (PICS): A New Horizon for Surgical Critical Care Subtitle. Kidney Response to Sepsis Affects Angiogenic Balance and Likelihood of CCI and PICS
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
GFR assessment will be determined at approximately day 14 or approximately at the day of discharge from the ICU and at the one-year follow-up:
- Determine GFR by Iohexol clearance and/or
- Estimated GFR by urea concentration and creatinine clearance
- Estimated GFR using calculations with serum creatinine
Study Type
Interventional
Enrollment (Actual)
73
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610
- UF Health at Shands hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Presence in the surgery or trauma ICU
- Age of ≥18 years
- Entrance into our sepsis protocol
- Ability to obtain informed consent.
Exclusion Criteria:
- Expected lifespan of the patient is less than 3 months due to severe pre-existing comorbidities (ex. recurrent, advanced or metastatic cancer)
- Severe traumatic brain injury (evidence of neurologic injury on CT scan and a GCS <8)
- Refractory shock (i.e., patients who die within 12 hours)
- Uncontrollable source of sepsis (e.g., irreversible disease state such as unresectable dead bowel)
- Patient or patient's family are not committed to aggressive management of the patient's condition and/or the patient has a DNR/DNI on file.
- Severe CHF (NY Heart Association Class IV)
- Child-Pugh C liver disease or pre-liver transplant.
- Known HIV infection with CD4 count <200 cells/mm3
- Organ transplant recipient on immunosuppressive agents
- Known pregnancy and mother's that are breastfeeding
- Prisoners
- Institutionalized patients
- Inability to obtain informed consent.
- Chemotherapy or radiotherapy within 30 days prior to sepsis.
- End stage renal disease on admission.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Inhospital group at day 14
This group of sepsis participants remain hospitalized at day 14.
GFR assessment is performed at inpatient day 14 and again at 1 year follow up.
|
Participants may receive a normal saline dilution of Iohexol 0.5-1 ml given by IV push.
Blood or urine will be collected and measured to determine glomerular filtration rate measurements.
This test will be repeated in one year.
Other Names:
Both groups of sepsis participants will have urine collected for at least 4 hours to as long as 24 hours or more.
The urine volume determined and a sample sent to the lab for determination of creatinine and urea concentration.
This test will be repeated in one year.
Both groups of sepsis participants will provide peripheral blood samples to the research staff.
The samples will be sent to the laboratory for serum creatinine results.
This test will be repeated in one year.
|
|
Active Comparator: Discharged prior to 14 days
The group of patients were discharged before 14 days.
GFR assessment at time of discharge and again at 1 year follow up.
|
Participants may receive a normal saline dilution of Iohexol 0.5-1 ml given by IV push.
Blood or urine will be collected and measured to determine glomerular filtration rate measurements.
This test will be repeated in one year.
Other Names:
Both groups of sepsis participants will have urine collected for at least 4 hours to as long as 24 hours or more.
The urine volume determined and a sample sent to the lab for determination of creatinine and urea concentration.
This test will be repeated in one year.
Both groups of sepsis participants will provide peripheral blood samples to the research staff.
The samples will be sent to the laboratory for serum creatinine results.
This test will be repeated in one year.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delta Curve Between Calculated GFR and GFR Measured by Iohexol at Baseline
Time Frame: For Arm 1 baseline is measured GFR at 14 days inhospital with sepsis or sepsis diagnosis. For Arm 2 baseline is measured GFR at discharge date prior to day 14 of hospitalizaton with sepsis or sepsis diagnosis.
|
The difference between a measured GFR with Iohexol and calculated GFR from creatinine.
|
For Arm 1 baseline is measured GFR at 14 days inhospital with sepsis or sepsis diagnosis. For Arm 2 baseline is measured GFR at discharge date prior to day 14 of hospitalizaton with sepsis or sepsis diagnosis.
|
|
Delta Curve Between Calculated GFR and GFR Measured by Iohexol at 1 Year Follow-up.
Time Frame: one year follow up for both arms
|
The difference between a measured GFR with Iohexol and calculated GFR from creatinine This was a one-time determination at 1 year follow-up
|
one year follow up for both arms
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Estimated GFR by Serum Creatinine
Time Frame: at 14 days inpatient hospitalization or at discharge date prior to day 14 inpatient hospitalization
|
The correlation between iohexol glomerular filtration rate and estimated glomerular filtration rate using previously validated equation applied to serum creatinine in both groups.
|
at 14 days inpatient hospitalization or at discharge date prior to day 14 inpatient hospitalization
|
|
Estimated GFR by Serum Creatinine
Time Frame: at 1 year follow-up
|
The correlation between iohexol glomerular filtration rate and estimated glomerular filtration rate using previously validated equation applied to serum creatinine in both groups.
|
at 1 year follow-up
|
|
Calculated GFR by Urea Concentration and Creatinine Clearance
Time Frame: at 14 days inpatient hospitalization or at discharge date prior to day 14 inpatient hospitalization
|
The urine will be collected for at least 4 hours to as long as 24 hours or more.
The urine volume determined and a sample sent to the lab for determination of creatinine and urea concentration
|
at 14 days inpatient hospitalization or at discharge date prior to day 14 inpatient hospitalization
|
|
Calculated GFR by Urea Concentration and Creatinine Clearance
Time Frame: at one year follow-up
|
The urine will be collected for at least 4 hours to as long as 24 hours or more.
The urine volume determined and a sample sent to the lab for determination of creatinine and urea concentration
|
at one year follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Segal, M.D., University of Florida
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2015
Primary Completion (Actual)
May 20, 2023
Study Completion (Actual)
May 20, 2023
Study Registration Dates
First Submitted
October 23, 2014
First Submitted That Met QC Criteria
October 23, 2014
First Posted (Estimated)
October 27, 2014
Study Record Updates
Last Update Posted (Actual)
July 9, 2024
Last Update Submitted That Met QC Criteria
June 13, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201400795-N
- P50GM111152-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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