NCT01978158

Brief Summary

Oxygen is a widely available gas that is cheap, easy to get and extensively used in medicine. From animal studies it has become apparent that increasing or lowering the degree of oxygen in the blood, the inflammatory response can be altered. We will investigate of this is also true in humans by increasing, lowering or keeping oxygen levels normal while giving healthy subjects a short inflammatory stimulus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

2 months

First QC Date

October 31, 2013

Last Update Submit

May 19, 2015

Conditions

HypoxiaNormoxiaHyperoxia

Keywords

OxygenHypoxiaHyperoxiaInflammationInnate immunity

Outcome Measures

Primary Outcomes (1)

  • Plasma TNF-alpha concentration following LPS administration

    Plasma TNF-α concentration after LPS administration (Area Under Curve); comparison of subjects treated with hypoxia compared to normoxia and hyperoxia compared to hypoxia

    1 day

Secondary Outcomes (28)

  • Hypoxia Inducible Factor 1 alpha in circulating leukocytes

    1 day

  • Hypoxia Inducible Factor mRNA and anti Hypoxia Inducible Factor mRNA in circulating leukocytes

    24 hours

  • Reactive Oxygen Species in circulating leukocytes

    1 day

  • Phagocytic function of circulating leukocytes

    1 day

  • cytokine production after ex vivo stimulation of leukocytes

    1 day

  • +23 more secondary outcomes

Study Arms (3)

Hypoxia

EXPERIMENTAL

Subjects will be breathing an individualized mix of nitrogen and room air titrated to an oxygen saturation of 80-85%.

Drug: Lipopolysaccharide

Hyperoxia

EXPERIMENTAL

Subjects will be breathing 100% of oxygen

Drug: Lipopolysaccharide

Normoxia

ACTIVE COMPARATOR

Subjects wil be breathing room air (21%)

Drug: Lipopolysaccharide

Interventions

LipopolysaccharideDRUG

LPS is used to elicit an inflammatory response in all subjects

Also known as: Purified LPS from Escherischa coli (O:113)
HyperoxiaHypoxiaNormoxia

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent to participate in this trial
  • Male subjects aged 18 to 35 years inclusive
  • Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory parameters

You may not qualify if:

  • Use of any medication(including herbal remedies and vitamin/mineral supplements) or recreational drugs within 7 days prior to profiling day
  • Smoking
  • Use of caffeine, or alcohol or within 1 day prior to profiling day
  • Previous participation in a trial where LPS was administered
  • Surgery or trauma with significant blood loss or blood donation within 3 months prior to profiling day
  • Participation in another clinical trial within 3 months prior to profiling day.
  • History, signs or symptoms of cardiovascular disease
  • An implant that in the opinion of the investigator may make invasive procedures risky for the subject due to the increased risks associated with a possible infection.
  • Subject has an implanted active cardiac device (ICD, IPG and/or CRT) Implanted active neurostimulation device
  • Subject has internal jugular vein that cannot be accessed
  • History of vaso-vagal collapse or of orthostatic hypotension
  • History of atrial or ventricular arrhythmia
  • Resting pulse rate ≤45 or ≥100 beats / min
  • Hypertension (RR systolic \>160 or RR diastolic \>90)
  • Hypotension (RR systolic \<100 or RR diastolic \<50)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Medicine

Nijmegen, Gelderland, 6500HB, Netherlands

Location

MeSH Terms

Conditions

HypoxiaHyperoxiaInflammation

Interventions

Lipopolysaccharides

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

GlycoconjugatesCarbohydratesPolysaccharides, BacterialPolysaccharidesLipidsAntigens, BacterialAntigensBiological FactorsEndotoxinsBacterial ToxinsToxins, Biological

Study Officials

  • Peter Pickkers, MD, PhD

    Intensive Care Medicine, Radboud University Nijmegen Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 7, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

NL(1)