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Completed

NCT Number: NCT02276066

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Health at Shands hospital

Gainesville, Florida, 32610, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GFR by Iohexol

Diagnostic Test

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: omnipaque

Urine collection

Diagnostic Test

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.

Blood samples

Diagnostic Test

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Oct 27, 2014
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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