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NCT02501044 Clinical Trial

Oxygen Desaturation During Hemodialysis

Hypoxia Clinical Trial

Official title:
Oxygen Desaturation During Hemodialysis: Clinical Correlates and Association With Adverse Outcomes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02501044
Other study ID # 14-446
Secondary ID
Status Completed
Phase N/A
First received July 9, 2015
Last updated July 15, 2015
Start date January 2012
Est. completion date January 2015

Study information
Verified date July 2015
Source Renal Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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:

1. The cumulative number, severity, or other characteristics of such deoxygenation episodes may be a predictor of adverse outcomes in hemodialysis patients.

2. 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.

Recruitment information / eligibility
Status Completed
Enrollment 5500
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Hemodialysis patient

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Renal Research Institute New York New York

Sponsors (1)
Lead Sponsor Collaborator
Renal Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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