Oxygen Desaturation During Hemodialysis | NCT02501044

Studies
Oxygen Desaturation During Hemodialysis

NCT02501044

Sponsor

Renal Research Institute

Status

Completed

Last Update Posted

Jul 17, 2015Estimated

Enrollment

5,500Actual

Phase

Not provided

Conditions

Renal Disease
Hypoxia

Interventions

Not provided

Countries

United States

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

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

Jul 9, 2015

First Submission Date that Met QC Criteria

Jul 15, 2015

First Posted Date

Jul 17, 2015Estimated

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

Jul 15, 2015

Last Update Posted Date

Jul 17, 2015Estimated

Description Module

Brief Summary

Hemodialysis patients may experience drops in blood oxygen saturation during the hemodialysis treatment, which may lead to hypoxia in the tissues.

The investigators hypothesize that:

The cumulative number, severity, or other characteristics of such deoxygenation episodes may be a predictor of adverse outcomes in hemodialysis patients.
There may be demographic, anthropometric, clinical, treatment prescription, lab analytical, and other parameters that correlate with the number and severity of deoxygenation episodes and, therefore, may be used for risk stratification. Further, some of these parameters may be modifiable.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

5,500Actual

Label	Type	Description	Intervention Names
Hemodialysis Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cumulative number of deoxygenation episodes	Crit-Line III monitor recordings (which contain oxygen saturation data) will be extracted from the RRI database and the cumulative number of deoxygenation episodes will be analyzed.	Up to 36 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hemodialysis patient

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Renal Research Institute hemodialysis patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Kotanko, MD	Renal Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renal Research Institute		New York	New York	10065	United States

Condition Browse Module

MeSH Terms

ID	Term
D007674	Kidney Diseases
D000860	Hypoxia

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided