NCT02129400

Brief Summary

The purpose of this study is to analyze the effect of xenon-inhalation on erythropoetin-level in blood of healthy volunteers and to determine the efficient time of inhalation. Hypothesis: Xenon-inhalation enhances erythropoetin-levels in blood

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_3 healthy-volunteers

Timeline
Completed

Started May 2014

Shorter than P25 for phase_3 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
terminated

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

April 15, 2014

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

8 months

First QC Date

April 15, 2014

Last Update Submit

March 30, 2015

Conditions

Healthy Volunteers

Keywords

Xenon-inhalationErythropoetinPharmakokineticPharmacodynamicHemodynamic parametersInflammatory parametersGrowth factorsOxidative stress parameters

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in erythropoetin-level in blood of healthy volunteers up to 216 hrs after the first of three xenon applications in total

    Change from baseline in erythropoetin-level in blood of healthy volunteers up to 216 hrs after the first of three xenon applications in total. Timepoints of measurement: Before each inhalation, Directly after the first inhalation, 2 hrs after the first inhalation, 4 hrs after the first inhalation, 8 hrs after the first inhalation, 22-24 hrs after each inhalation, 46-48 hrs after each inhalation, 70-72 hrs after the last inhalation, 94-96 hrs after the last inhalation, 118-120 hrs after the last inhalation

    up to 216 hrs after first xenon-application

Secondary Outcomes (1)

  • First-order elimination of xenon after xenon-inhalation in blood and exhalation air by mass-spectroscopy

    up to 216 hrs after the first xenon-application

Other Outcomes (3)

  • Determination of hemodynamic parameters (HF, RR, EKG, SpO2, rSO2, tSO2)

    up to 216 hrs after the first xenon-application

  • Laboratory parameters: Inflammation (procalcitonin, IL-6, IL-10, leukocytes, thrombocytes), growth factors (HIF1α, FGFs, HGF, MGFs, PDGF, VEGF, IL-8, VEGF, MIF, SDF-1a)

    up to 216 hrs after the first xenon-application

  • Oxidative stress: total oxidative capacity, peroxide activity, LDL antibodies: antibody against oxided LDL, e.g. MDA-LDL IgM, oLAb (IgG)

    up to 216 hrs after the first xenon-application

Study Arms (16)

10min Xenon 15%, FiO2 75%

EXPERIMENTAL

10 minutes of 15 % xenon-inhalation (with 75 % FiO2)

Drug: Xenon pro Anaesthesia 100 % (V/V)

10min Xenon 30%, FiO2 60%

EXPERIMENTAL

10 minutes of 30 % xenon-inhalation (with 60 % FiO2)

Drug: Xenon pro Anaesthesia 100 % (V/V)

30min Xenon 15%, FiO2 75%

EXPERIMENTAL

30 minutes of 15 % xenon-inhalation (with 75 % FiO2)

Drug: Xenon pro Anaesthesia 100 % (V/V)

30min Xenon 30%, FiO2 60%

EXPERIMENTAL

30 minutes of 30 % xenon-inhalation (with 60 % FiO2)

Drug: Xenon pro Anaesthesia 100 % (V/V)

45min Xenon 15%, FiO2 75%

EXPERIMENTAL

45 minutes of 15 % xenon-inhalation (with 75 % FiO2)

Drug: Xenon pro Anaesthesia 100 % (V/V)

45min Xenon 30%, FiO2 60%

EXPERIMENTAL

45 minutes of 30 % xenon-inhalation (with 60 % FiO2)

Drug: Xenon pro Anaesthesia 100 % (V/V)

90min Xenon 15%, FiO2 75%

EXPERIMENTAL

90 minutes of 15 % xenon-inhalation (with 75 % FiO2)

Drug: Xenon pro Anaesthesia 100 % (V/V)

90min Xenon 30%, FiO2 60%

EXPERIMENTAL

90 minutes of 30 % xenon-inhalation (with 60 % FiO2)

Drug: Xenon pro Anaesthesia 100 % (V/V)

10min air medicinalis, FiO2 75%

PLACEBO COMPARATOR

10 minutes of air medicinalis (with 75 % FiO2)

Drug: Aer medicinalis Linde 100%

10min air medicinalis, FiO2 60%

PLACEBO COMPARATOR

10 minutes of air medicinalis inhalation (with 60 % FiO2)

Drug: Aer medicinalis Linde 100%

30min air medicinalis, FiO2 75%

PLACEBO COMPARATOR

30 minutes of air medicinalis inhalation (with 75 % FiO2)

Drug: Aer medicinalis Linde 100%

30min air medicinalis, FiO2 60%

PLACEBO COMPARATOR

30 minutes of air medicinalis inhalation (with 60 % FiO2)

Drug: Aer medicinalis Linde 100%

45min air medicinalis, FiO2 75%

PLACEBO COMPARATOR

45 minutes of air medicinalis inhalation (with 75 % FiO2)

Drug: Aer medicinalis Linde 100%

45min air medicinalis, FiO2 60%

PLACEBO COMPARATOR

45 minutes of air medicinalis inhalation (with 60 % FiO2)

Drug: Aer medicinalis Linde 100%

90min air medicinalis, FiO2 75%

PLACEBO COMPARATOR

90 minutes of air medicinalis inhalation (with 75 % FiO2)

Drug: Aer medicinalis Linde 100%

90min air medicinalis, FiO2 60%

PLACEBO COMPARATOR

90 minutes of air medicinalis inhalation (with 60 % FiO2)

Drug: Aer medicinalis Linde 100%

Interventions

Xenon pro Anaesthesia 100 % (V/V)DRUG

Xenon-gas inhalation of indicated concentrations during indicated time

Also known as: licence number: 56582.00.00
10min Xenon 15%, FiO2 75%10min Xenon 30%, FiO2 60%30min Xenon 15%, FiO2 75%30min Xenon 30%, FiO2 60%45min Xenon 15%, FiO2 75%45min Xenon 30%, FiO2 60%90min Xenon 15%, FiO2 75%90min Xenon 30%, FiO2 60%
Aer medicinalis Linde 100%DRUG
Also known as: Pharmakotherapeutic group: medical gas, Licence number: 68885.00.00, ATC-Code: V03AN05
10min air medicinalis, FiO2 60%10min air medicinalis, FiO2 75%30min air medicinalis, FiO2 60%30min air medicinalis, FiO2 75%45min air medicinalis, FiO2 60%45min air medicinalis, FiO2 75%90min air medicinalis, FiO2 60%90min air medicinalis, FiO2 75%

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male subjects
  • Age: \> 18 years
  • legally competent to sign
  • without any known medical condition or medication prescribed at the University Hospital RWTH Aachen, Germany
  • Persons that are able and willing to understand and follow the instructions of the study personnel
  • Signed informed consent

You may not qualify if:

  • Smoker, alcoholic or person who regularly consumes drugs or medication
  • Persons with a medical condition that is contraindicated with the planned treatment
  • Known hypersensitivity against xenon
  • Persons not legally competent to sign
  • Simultaneous participation at any other trial
  • Blood-loss due to trauma during the period of the study or 2 months previous
  • Blood donation during the period of the study or 2 months previous

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital RWTH Aachen, Department for Anesthesia

Aachen, North-Rhine Westfalia, 52074, Germany

Location

Study Officials

  • Rolf Rossaint, Prof. M.D.

    University Hospital RWTH Aachen, Department for Anesthesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2014

First Posted

May 2, 2014

Study Start

May 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations

DE(1)