NCT02928887

Brief Summary

The goal of this study is to determine whether or not exposure to blue spectrum light reduces acute kidney injury and systemic inflammation in subjects undergoing cardiopulmonary bypass. Subjects scheduled to undergo cardiopulmonary bypass surgery will be exposed to either bright (1000 lux) blue spectrum (480nm) light or to ambient, white fluorescent light for a 24 hour photoperiod the day prior to surgery and for a 24 hour photoperiod in the immediate postoperative period.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
3.9 years until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

1.4 years

First QC Date

October 5, 2016

Last Update Submit

January 19, 2022

Conditions

Acute Kidney InjuryInflammation

Outcome Measures

Primary Outcomes (2)

  • Change in creatinine concentration

    The change in serum creatinine after intervention compared to baseline.

    Change in serum creatinine concentration at 24 hours after surgery compared to preoperative baseline creatinine concentration

  • Change in blood urea nitrogen (BUN) concentration

    The change in serum BUN after intervention compared to baseline.

    Change in serum BUN concentration at 24 hours after surgery compared to preoperative baseline BUN concentration

Secondary Outcomes (6)

  • Inflammation

    Change in serum cytokine concentrations comparing serum concentrations at 24 hours after surgery to serum concentrations immediately (with 1 hour) after surgery

  • all cause mortality

    within 28 days after surgery

  • duration of ICU stay

    within 28 days after surgery

  • duration of hospital stay

    within 28 days after surgery

  • Ventilator-free days

    within 28 days after surgery

  • +1 more secondary outcomes

Study Arms (2)

Blue light

EXPERIMENTAL

Exposure to high illuminance (1000 lux), blue spectrum (480nm) light for the 24 hour photoperiod prior to surgery and for the 24 hour photoperiod immediately after surgery

Other: Blue light

Ambient light

NO INTERVENTION

Exposure to ambient, white fluorescent light

Interventions

Blue lightOTHER

Exposure to high illuminance (1000 lux), blue spectrum (480 nm) light for a 24-hour photoperiod immediately before surgery and a 24-hour photoperiod immediately after surgery

Blue light

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age greater than or equal to 18 years
  • undergoing cardiopulmonary bypass surgery

You may not qualify if:

  • Blindness
  • Immunocompromised or immunosuppressed state
  • Anticipated survival \< 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

  • Yuan D, Collage RD, Huang H, Zhang X, Kautza BC, Lewis AJ, Zuckerbraun BS, Tsung A, Angus DC, Rosengart MR. Blue light reduces organ injury from ischemia and reperfusion. Proc Natl Acad Sci U S A. 2016 May 10;113(19):5239-44. doi: 10.1073/pnas.1515296113. Epub 2016 Apr 25.

    PMID: 27114521BACKGROUND

  • Castro RA, Angus DC, Hong SY, Lee C, Weissfeld LA, Clermont G, Rosengart MR. Light and the outcome of the critically ill: an observational cohort study. Crit Care. 2012 Jul 24;16(4):R132. doi: 10.1186/cc11437.

    PMID: 22827924BACKGROUND

MeSH Terms

Conditions

Acute Kidney InjuryInflammation

Interventions

Blue Light

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LightElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaOptical PhenomenaRadiationRadiation, Nonionizing

Study Officials

  • Matthew R Rosengart, MD MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 5, 2016

First Posted

October 10, 2016

Study Start

September 1, 2020

Primary Completion

January 19, 2022

Study Completion

June 30, 2022

Last Updated

January 20, 2022

Record last verified: 2022-01

Locations

US(1)