SepsisNCT02276066

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

A study testing GFR by Iohexol, Urine Collection and Blood samples in people with Sepsis, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Sepsis
What is being tested?: GFR by Iohexol, Urine Collection and Blood samples
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 73 participants
Where: 1 siteUnited States
Study dates: Feb 2015to 20 May 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Presence in the surgery or trauma ICU
Age of ≥18 years
Entrance into our sepsis protocol
Ability to obtain informed consent.

Who cannot join

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)

Show all 15Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

UF Health at Shands hospital
Gainesville, Florida, 32610

Other trials in United States

About this study

Official 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

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.

Read the 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

Conditions: Sepsis
Being tested: GFR by Iohexol, Urine Collection, Blood samples
Keywords: kidney dysfunction, chronic critical illness, sepsis, Glomerular filtration rate
Medical subject headings: Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GFR by IohexolDiagnostic test
Also called omnipaque
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.
Urine CollectionDiagnostic 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 samplesDiagnostic 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.

Study groups in NCT02276066
Study group	Role	What they receive
Inhospital group at day 14	Experimental	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. Receives: Diagnostic Test: GFR by Iohexol; Diagnostic Test: Urine Collection; Diagnostic Test: Blood samples
Discharged prior to 14 days	Active comparator	The group of patients were discharged before 14 days. GFR assessment at time of discharge and again at 1 year follow up. Receives: Diagnostic Test: GFR by Iohexol; Diagnostic Test: Urine Collection; Diagnostic Test: Blood samples

What is being measured

The primary outcome is the main question the study is designed to answer.

Delta Curve Between Calculated GFR and GFR Measured by Iohexol at Baseline
The difference between a measured GFR with Iohexol and calculated GFR from creatinine.
Measured: 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.
The difference between a measured GFR with Iohexol and calculated GFR from creatinine This was a one-time determination at 1 year follow-up
Measured: one year follow up for both arms

Secondary outcomes (4)

Estimated GFR by Serum Creatinine
The correlation between iohexol glomerular filtration rate and estimated glomerular filtration rate using previously validated equation applied to serum creatinine in both groups.
Measured: at 14 days inpatient hospitalization or at discharge date prior to day 14 inpatient hospitalization
Estimated GFR by Serum Creatinine
The correlation between iohexol glomerular filtration rate and estimated glomerular filtration rate using previously validated equation applied to serum creatinine in both groups.
Measured: at 1 year follow-up
Calculated GFR by Urea Concentration and Creatinine Clearance
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
Measured: at 14 days inpatient hospitalization or at discharge date prior to day 14 inpatient hospitalization
Calculated GFR by Urea Concentration and Creatinine Clearance
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
Measured: at one year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 201520 May 2023

First posted27 Oct 2014 (estimated)
Study startFeb 2015
Primary completion20 May 2023
Study completion20 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SepsisStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 73 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02276066
Sponsor's protocol ID: IRB201400795-N
Other IDs: P50GM111152-01
Status last verified: Jun 2024
First submitted: 23 Oct 2014
Last updated: 9 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Loftus TJ, Wu Q, Wang Z, Lysak N, Moore FA, Bihorac A, Efron PA, Mohr AM, Brakenridge SC. Delayed interhospital transfer of critically ill patients with surgical sepsis. J Trauma Acute Care Surg. 2020 Jan;88(1):169-175. doi: 10.1097/TA.0000000000002476.
PubMed 31856021

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock

All Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT02276066
Acronym / sponsor ID: IRB201400795-N
Conditions: Sepsis
Keywords: kidney dysfunction, chronic critical illness, sepsis, Glomerular filtration rate
Study type: Interventional
Recruitment status: Completed
Enrolment: 73 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
Study start: Feb 2015 (actual)
Primary completion: 20 May 2023 (actual)
Study completion: 20 May 2023 (actual)
First posted: 27 Oct 2014 (estimated)
Results: Posted 9 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Inhospital group at day 14	Experimental	Diagnostic Test: GFR by Iohexol, Diagnostic Test: Urine Collection, Diagnostic Test: Blood samplesThis group of sepsis participants remain hospitalized at day 14. GFR assessment is performed at inpatient day 14 and again at 1 year follow up.
Discharged prior to 14 days	Active comparator	Diagnostic Test: GFR by Iohexol, Diagnostic Test: Urine Collection, Diagnostic Test: Blood samplesThe group of patients were discharged before 14 days. GFR assessment at time of discharge and again at 1 year follow up.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Presence in the surgery or trauma ICU
Age of ≥18 years
Entrance into our sepsis protocol
Ability to obtain informed consent.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GFR by IohexolAlso: omnipaqueParticipants 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.	Diagnostic test	Discharged prior to 14 days, Inhospital group at day 14
Urine CollectionBoth 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.	Diagnostic test	Discharged prior to 14 days, Inhospital group at day 14
Blood samplesBoth 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.	Diagnostic test	Discharged prior to 14 days, Inhospital group at day 14

Primary outcome

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.
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

4 secondary outcomes

Estimated GFR by Serum Creatinine
Time frame: 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
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
Calculated GFR by Urea Concentration and Creatinine Clearance
Time frame: at one year follow-up

Results and safety

Results posted to the registry on 9 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Inhospital Group at Day 14	41	20
Discharged Prior to Hospital Day 14	32	21

Primary outcome: 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.. Mean (Standard Deviation). Unit: ml/min/1.73m2

Measure	Inhospital Group at Day 14 n = 41	Discharged Prior to Day 14 GFR n = 32
Iohexol GFR	91.5 (46.0)	88.3 (39.0)
eGFR by epi formula	93.6 (26.6)	90.0 (28.7)

Inhospital Group at Day 14 vs Discharged Prior to Day 14 GFR: p <0.05, Delta analysis

Population analysed: GFR by iohexol and eGFR by CKD epi at baseline. The iohexol could not be performed on many patients because it was contraindicated

Primary outcome: Delta Curve Between Calculated GFR and GFR Measured by Iohexol at 1 Year Follow-up.

Time frame: one year follow up for both arms. Mean (Standard Deviation). Unit: mL/min/1.73m2

Measure	Inhospital Group at Day 14 n = 3	Discharged Prior to 14 Days n = 6
Value	71.4 (38.6)	58.8 (40.9)

Population analysed: The iohexol could not be performed in many individuals because they could not come in to the clinic, would not come into the clinic, or the iohexol injection was contraindicated.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Inhospital Group at Day 14	24 of 41 (58.5%)	0 of 41 (0%)	6 of 41
Discharged From Hospital Prior to Day 14	15 of 32 (46.9%)	0 of 32 (0%)	1 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31856021Loftus TJ, Wu Q, Wang Z, Lysak N, Moore FA, Bihorac A, Efron PA, Mohr AM, Brakenridge SC. Delayed interhospital transfer of critically ill patients with surgical sepsis. J Trauma Acute Care Surg. 2020 Jan;88(1):169-175. doi: 10.1097/TA.0000000000002476.

Related trials for Sepsis

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Segal, M.D. principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing GFR by Iohexol, Urine Collection and Blood samples in people with Sepsis, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02276066, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.