NCT02501044

Completed

Oxygen Desaturation During Hemodialysis

Renal Research Institute Source

Other study identifiers

Sponsor study identifier

14-446

Study Type

observational

Actual enrollment (reported)

5,500

Locations

1 country

Sites

1

Timeline

Study Start

January 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2015

Actual (reported)

Study Completion

January 2015

Actual (reported)

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:

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 5,500 participants
Study completion date: January 2015
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2012
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
January 2015
Actual (reported)
Study Completion
January 2015
Actual (reported)
First Submitted
July 9, 2015
Actual (reported)
First Posted
July 17, 2015
Actual (reported)

Last Updated: July 17, 2015
Status Verified: July 2015
Last Update Submitted: July 15, 2015

Conditions

Hypoxia Renal Disease

Outcome Measures

Primary Outcomes (1)

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

Study Arms (1)

Hemodialysis Patients

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Renal Research Institute hemodialysis patients

You may qualify if:

Hemodialysis patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Renal Research Institute
Otherlead

Study Sites (1)

Renal Research Institute

New York, New York, 10065, United States

MeSH Terms

Conditions

Kidney DiseasesHypoxia

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Peter Kotanko, MD
Renal Research Institute
PRINCIPAL INVESTIGATOR

Enrollment

5,500 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: RETROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 9, 2015

First Posted

July 17, 2015

Study Start

January 2012

Date type not reported

This date has not been verified as actual or estimated.

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Primary Completion

January 2015

Actual (reported)

Study Completion

January 2015

Actual (reported)

Last Updated

July 17, 2015

Record last verified: 2015-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02501044
Data provider: ClinicalTrials.gov
Source updated: 2015-07-17
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:10 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Hemodialysis Patients

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations