Acute Kidney InjuryNCT02915081
Blue Light Therapy for Liver Surgery
A study testing Blue light in people with Acute Kidney Injury and Liver Injury, run by University of Pittsburgh at 1 site in United States.
Trial summary
The investigators hypothesize that subjects undergoing liver resection and who are exposed preoperatively to high illuminance blue spectrum light will exhibit reduced organ injury, specifically liver dysfunction, than subjects exposed to standard ambient white fluorescent light. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury, Liver Injury, Inflammation
- What is being tested?
- Blue light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 31 Dec 2018
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age greater than 17 years
- undergoing right or left hepatic lobectomy
Who cannot join
- presence of acute traumatic brain injury
- blindness
- immunosuppression or immunocompromised condition
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
The investigators hypothesize that subjects undergoing liver resection and who are exposed preoperatively to high illuminance blue spectrum light will exhibit reduced organ injury, specifically liver dysfunction, than subjects exposed to standard ambient white fluorescent light.
- Conditions
- Acute Kidney Injury, Liver Injury, Inflammation
- Being tested
- Blue light
- Medical subject headings
- Acute Kidney Injury, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue lightOther
Illumination: High illumination lighting will be instituted with a Day*Light Classic Light (Uplift Technologies, Dartmouth, NS)
Blue wavelength: Each subject will be fitted with blue filtered goggles (Lee Filters, Burbank, CA). These goggles ensure the transmission of a bright (1700 lux) blue (peak 442 nm) spectrum light when the subject is within 12 inches.
Photoperiod: A 24-hour photoperiod will be used that commences at 0800 the morning prior to surgery and continues for 24 hours. To account for potential variability in the exposure of interest, each subject will complete a diary to catalogue duration and distance of light exposure. Postoperatively the same photoperiod will be instituted and continued for one 24 hour period.
| Study group | Role | What they receive |
|---|---|---|
| Blue light | Experimental | Subjects will be exposed to 24 hours of bright (1700 lux) blue (peak 442 nm) spectrum light the day prior to operative intervention and for the 24 hours after the operative intervention. Receives: Other: Blue light |
| Ambient light | No intervention | Subjects will be exposed preoperatively to the lighting conditions of their living environment and postoperatively to the standard, white fluorescent lighting environment of the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline creatinine concentration at 24 hours after surgery
a serum marker of acute kidney injury
Measured: preoperatively and 24 hours after surgery
Change from baseline alanine aminotransferase (ALT) concentration at 24 hours after surgery
a serum marker of acute liver injury
Measured: preoperatively and 24 hours after surgery
Secondary outcomes (5)
Change in serum cytokine concentrations at 24 hours after surgery
serum will be analyzed for cytokines and inflammatory mediators
Measured: 24 hours after surgery
Ventilator-free days
Measured: for the duration of postoperative inpatient hospital stay up to 28 days
ICU length of stay
Measured: for the duration of postoperative inpatient hospital stay up to 28 days
renal replacement therapy
Measured: for the duration of postoperative inpatient hospital stay up to 28 days
Change in serum cytokine concentrations at 1 hour after surgery
serum will be analyzed for cytokines and inflammatory mediators
Measured: 1 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start1 Jan 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Why it stopped: low anticipated recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Pittsburgh Medical Center
- Responsible party
- Principal investigator, Allan Tsung, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915081
- Sponsor's protocol ID
- PRO13080427
- Status last verified
- Apr 2019
- First submitted
- 10 Sep 2016
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This trial is a small pilot trial.
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blue Light Therapy for Liver Surgery
- ClinicalTrials.gov ID
- NCT02915081
- Acronym / sponsor ID
- PRO13080427
- Conditions
- Acute Kidney Injury, Liver Injury, Inflammation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low anticipated recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Pittsburgh Medical Center
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 26 Sep 2016 (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.
The investigators hypothesize that subjects undergoing liver resection and who are exposed preoperatively to high illuminance blue spectrum light will exhibit reduced organ injury, specifically liver dysfunction, than subjects exposed to standard ambient white fluorescent light.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blue light | Experimental | Other: Blue lightSubjects will be exposed to 24 hours of bright (1700 lux) blue (peak 442 nm) spectrum light the day prior to operative intervention and for the 24 hours after the operative intervention. |
| Ambient light | No intervention | –Subjects will be exposed preoperatively to the lighting conditions of their living environment and postoperatively to the standard, white fluorescent lighting environment of the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age greater than 17 years
- undergoing right or left hepatic lobectomy
Key exclusion criteria (3 listed)
- presence of acute traumatic brain injury
- blindness
- immunosuppression or immunocompromised condition
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 |
|---|---|---|
| Blue lightIllumination: High illumination lighting will be instituted with a Day*Light Classic Light (Uplift Technologies, Dartmouth, NS) Blue wavelength: Each subject will be fitted with blue filtered goggles (Lee Filters, Burbank, CA). These goggles ensure the transmission of a bright (1700 lux) blue (peak 442 nm) spectrum light when the subject is within 12 inches. Photoperiod: A 24-hour photoperiod will be used that commences at 0800 the morning prior to surgery and continues for 24 hours. To account for potential variability in the exposure of interest, each subject will complete a diary to catalogue duration and distance of light exposure. Postoperatively the same photoperiod will be instituted and continued for one 24 hour period. | Other | Blue light |
Primary outcome
Change from baseline creatinine concentration at 24 hours after surgery
Time frame: preoperatively and 24 hours after surgery
a serum marker of acute kidney injury
Change from baseline alanine aminotransferase (ALT) concentration at 24 hours after surgery
Time frame: preoperatively and 24 hours after surgery
a serum marker of acute liver injury
5 secondary outcomes
Change in serum cytokine concentrations at 24 hours after surgery
Time frame: 24 hours after surgery
Ventilator-free days
Time frame: for the duration of postoperative inpatient hospital stay up to 28 days
ICU length of stay
Time frame: for the duration of postoperative inpatient hospital stay up to 28 days
renal replacement therapy
Time frame: for the duration of postoperative inpatient hospital stay up to 28 days
Change in serum cytokine concentrations at 1 hour after surgery
Time frame: 1 hours after surgery
Results and safety
The study was stopped early (reason given: low anticipated recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Individual participant dataSharing planned: Undecided. This trial is a small pilot trial.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue light in people with Acute Kidney Injury and Liver Injury, run by University of Pittsburgh 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 5 Apr 2019. 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 was stopped early (reason given: low anticipated recruitment). Results are not available in the source record.
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?
Change from baseline creatinine concentration at 24 hours after surgery (time frame: preoperatively and 24 hours after surgery). 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?
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 5 Apr 2019.