Hemodynamic Changes in Altitude Adaptation | NCT01698619

Studies
Hemodynamic Changes in Altitude Adaptation

NCT01698619

Sponsor

Goethe University

Status

Unknown status

Last Update Posted

Oct 3, 2012Estimated

Enrollment

12Estimated

Phase

Not provided

Conditions

Acute Mountain Sickness
High Altitude Pulmonary Edema
High Altitude Cerebral Edema

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Sep 27, 2012

First Submission Date that Met QC Criteria

Oct 2, 2012

First Posted Date

Oct 3, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2012

Last Update Posted Date

Oct 3, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We use a new technology (Nexfin from BMEYE-Inventive Hemodynamics) to monitor Cardiac Output, Blood Pressure, Fluid Responsiveness, Pulse Oximetry, Hemoglobin Concentration, Oxygen Delivery in Climbers during their process of acclimatization on a expedition to Mount Aconcagua.

Detailed Description

Several parameters will be recorded to analyze their influence on the adaptation to high altitude. Such as, food composition, dietary supplements, water intake and output.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Climbers on Mount Aconcagua		The Cohort consists of volunteers climbing Mount Aconcagua.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes from baseline in Oxygen Delivery	Unit: ml/min baseline measure will be obtained at sea level	daily, up to 18 days

Secondary Outcomes

Measure	Description	Time Frame
Changes from baseline in Hemoglobin Concentration	Unit: mg/dl baseline measure will be obtained at sea level	daily, up to 18 days

Other Outcomes

Measure	Description	Time Frame
Changes from baseline in Blood pressure, Fluid Responsiveness, Oxygen Saturation, Cardiac Output	baseline measure will be obtained at sea level	daily, up to 18 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

No acute or chronic disease
Body mass index : 20 - 30

Exclusion Criteria:

Any preexisting disease that has a potential impact on physical performance such as:
- pulmonary
- cerebral
- muscular
- cardiac
- vascular - diseases

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

healthy volunteers taking part in an expedition to Mount Aconcagua

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Goethe University	Recruiting	Frankfurt am Main	Hesse	60590	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000532	Altitude Sickness

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided