SepsisCASSNCT03015584
Systems Biology Approach to Cognitive Impairment After SepsiS
An observational study of Sepsis and Cognitive Impairment, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
This study will use systems biology techniques, especially RNA-seq, to understand cognitive impairment after sepsis requiring an intensive care unit (ICU) admission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Cognitive Impairment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with sepsis or septic shock, admitted to the ICU.
Who may be able to join
- Either SEPSIS or SEPTIC SHOCK
- SEPSIS:
- PRESENCE OF
- Suspected or confirmed infection AND
- Organ dysfunction as defined by a SOFA >= 2 above baseline (if no baseline data available, SOFA assumed to be 0)
- OR
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- SEPTIC SHOCK:
- AFTER INTRAVENOUS INFUSION OF 20ML/KG CRYSTALLOID OR EQUIVALENT, PRESENCE OF
- Suspected or confirmed infection AND
- Lactate > 2 mmol/L AND
- Receiving vasopressors
- Enrollment within 48 hours of ICU admission.
- Must live within 200 miles of Intermountain Medical Center
- Subject is at least 18 years of age or older
- Must speak English
Who cannot join
- Onset of sepsis or septic shock >24 hours after hospital admission
- Patients transferred from another hospital except for directly from an emergency room
- Patients transferred to the ICU >48 hours after admission to Intermountain Medical Center (must have been admitted with diagnosis of sepsis)
- Prior traumatic brain injury, stroke, or intracranial hemorrhage
- DNR/DNI order before study enrollment
- Primary diagnosis of stroke or intracranial hemorrhage
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- Known preexisting dementia or substantial cognitive impairment of any cause (established from both chart review, report and/or score ≥3 on IQ Code screening.
- Prior cardiac surgery (coronary artery bypass grafting or surgical valve replacement or repair)
- Known schizophrenia or other psychotic thought disorder
- Known pregnancy
- Primary diagnosis of drug overdose
- Attending physician deems aggressive care unsuitable
- Enrolled in another study if that study involves drug interventions
- Not expected to survive 48 hours
- Has a terminal condition independent of the acute illness that is expected to lead to death within 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Intermountain Medical Center
Salt Lake City, Utah, 84157
About this study
Official title: Systems Biology Approach to Cognitive Impairment After SepsiS (CASS)
This study will use systems biology techniques, especially RNA-seq, to understand cognitive impairment after sepsis requiring an intensive care unit (ICU) admission.
- Conditions
- Sepsis, Cognitive Impairment
- Medical subject headings
- Sepsis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Septic patients admitted to the ICU | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hayling Sentence Completion test
Measures executive function. 6-month Hayling Sentence Completion test is the prespecified primary outcome.
Measured: 6 months
Secondary outcomes (25)
Wechsler Memory Scale Logical Memory 1 assessment
Measured: 3 months
Wechsler Memory Scale Logical Memory 1 assessment
Measured: 6 months
Wechsler Memory Scale Logical Memory 2 assessment
Measured: 3 months
Wechsler Memory Scale Logical Memory 2 assessment
Measured: 6 months
Digit Span memory assessment
Measured: 3 months
Digit Span memory assessment
Measured: 6 months
Verbal Fluency test
Measured: 3 months
Verbal Fluency test
Measured: 6 months
Wechsler Similarities assessment
Measured: 3 months
Wechsler Similarities assessment
Measured: 6 months
EuroQol five dimensions questionnaire (EQ-5D-3L)
Measured: 3 months
EuroQol five dimensions questionnaire (EQ-5D-3L)
Measured: 6 months
36-item short form survey (SF-36)
Measured: 3 months
36-item short form survey (SF-36)
Measured: 6 months
Hospital Anxiety and Depression Scale (HADS)
Measured: 3 months
Hospital Anxiety and Depression Scale (HADS)
Measured: 6 months
Impact of Event Scale-Revised (IES-R)
Measured: 3 months
Impact of Event Scale-Revised (IES-R)
Measured: 6 months
Functional Performance Inventory (FPI)
Measured: 3 months
Functional Performance Inventory (FPI)
Measured: 6 months
Functional Assessment of Chronic Illness Therapy (FACIT)
Measured: 3 months
Functional Assessment of Chronic Illness Therapy (FACIT)
Measured: 6 months
Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)
Measured: 3 months
Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)
Measured: 6 months
Hayling Sentence Completion test
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startJun 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah
- Responsible party
- Principal investigator, Samuel Brown, Intermountain Health Care, Inc.
- Investigators
- Samuel Brown, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015584
- Sponsor's protocol ID
- 1040524
- Acronym
- CASS
- Status last verified
- Jul 2018
- First submitted
- 8 Dec 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Brown SM, Collingridge DS, Wilson EL, Beesley S, Bose S, Orme J, Jackson J, Hopkins RO. Preliminary Validation of the Montreal Cognitive Assessment Tool among Sepsis Survivors: A Prospective Pilot Study. Ann Am Thorac Soc. 2018 Sep;15(9):1108-1110. doi: 10.1513/AnnalsATS.201804-233OC. No abstract available.
PubMed 30168744
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Biology Approach to Cognitive Impairment After SepsiS (CASS)
- ClinicalTrials.gov ID
- NCT03015584
- Acronym / sponsor ID
- CASS / 1040524
- Conditions
- Sepsis, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- University of Utah
- Study start
- Jun 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will use systems biology techniques, especially RNA-seq, to understand cognitive impairment after sepsis requiring an intensive care unit (ICU) admission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Septic patients admitted to the ICU | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sepsis or septic shock, admitted to the ICU.
Key inclusion criteria (15 listed)
- Either SEPSIS or SEPTIC SHOCK
- SEPSIS:
- PRESENCE OF
- Suspected or confirmed infection AND
- Organ dysfunction as defined by a SOFA >= 2 above baseline (if no baseline data available, SOFA assumed to be 0)
Key exclusion criteria (15 listed)
- Onset of sepsis or septic shock >24 hours after hospital admission
- Patients transferred from another hospital except for directly from an emergency room
- Patients transferred to the ICU >48 hours after admission to Intermountain Medical Center (must have been admitted with diagnosis of sepsis)
- Prior traumatic brain injury, stroke, or intracranial hemorrhage
- DNR/DNI order before study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hayling Sentence Completion test
Time frame: 6 months
Measures executive function. 6-month Hayling Sentence Completion test is the prespecified primary outcome.
25 secondary outcomes
Wechsler Memory Scale Logical Memory 1 assessment
Time frame: 3 months
Wechsler Memory Scale Logical Memory 1 assessment
Time frame: 6 months
Wechsler Memory Scale Logical Memory 2 assessment
Time frame: 3 months
Wechsler Memory Scale Logical Memory 2 assessment
Time frame: 6 months
Digit Span memory assessment
Time frame: 3 months
Digit Span memory assessment
Time frame: 6 months
Verbal Fluency test
Time frame: 3 months
Verbal Fluency test
Time frame: 6 months
Wechsler Similarities assessment
Time frame: 3 months
Wechsler Similarities assessment
Time frame: 6 months
EuroQol five dimensions questionnaire (EQ-5D-3L)
Time frame: 3 months
EuroQol five dimensions questionnaire (EQ-5D-3L)
Time frame: 6 months
36-item short form survey (SF-36)
Time frame: 3 months
36-item short form survey (SF-36)
Time frame: 6 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: 6 months
Impact of Event Scale-Revised (IES-R)
Time frame: 3 months
Impact of Event Scale-Revised (IES-R)
Time frame: 6 months
Functional Performance Inventory (FPI)
Time frame: 3 months
Functional Performance Inventory (FPI)
Time frame: 6 months
Functional Assessment of Chronic Illness Therapy (FACIT)
Time frame: 3 months
Functional Assessment of Chronic Illness Therapy (FACIT)
Time frame: 6 months
Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)
Time frame: 3 months
Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)
Time frame: 6 months
Hayling Sentence Completion test
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Derived from this study: PubMed 30168744Brown SM, Collingridge DS, Wilson EL, Beesley S, Bose S, Orme J, Jackson J, Hopkins RO. Preliminary Validation of the Montreal Cognitive Assessment Tool among Sepsis Survivors: A Prospective Pilot Study. Ann Am Thorac Soc. 2018 Sep;15(9):1108-1110. doi: 10.1513/AnnalsATS.201804-233OC. No abstract available.
- Individual participant dataSharing planned: No
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.
Samuel Brown, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Cognitive Impairment, run by Intermountain Health Care, Inc. 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 15 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 18 Jul 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hayling Sentence Completion test (time frame: 6 months). 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 NCT03015584, 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 18 Jul 2018.