A Prospective Study of Airless Tubing in an Inpatient Acute Hemodialysis Unit in Hospitalized Patients

NCT ID: NCT02086682

Last Updated: 2019-07-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

338 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-08-31

Brief Summary

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The introduction of unfractionated heparin (UFH), which prevents clotting of the extracorporal circuit, was one of the key advances that led to the rapid development and expansion of hemodialysis services. However, anticoagulation during hemodialysis of the patient at high risk for bleeding remains a frequently encountered problem in both inpatient and outpatient dialysis practice.

Streamline bloodlines are designed to eliminate blood-air contact. This is thought to help reduce heparin use and decrease clotting rates. The goal of this study was to prospectively examine impact of the Streamline airless blood tubing set, in an inpatient setting, on dialysis circuit clotting rates, anticoagulation use, and dialysis efficiency.

Detailed Description

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The introduction of unfractionated heparin (UFH), which prevents clotting of the extracorporeal circuit, was one of the key advances that led to the rapid development and expansion of hemodialysis use, and remains the mainstay in hemodialysis practice today.

However, anticoagulation during hemodialysis of the patient at high risk for bleeding remains a frequently encountered problem in the nephrology practice. The need for anticoagulation to prevent clotting of the extracorporeal blood circuit and the need to prevent anticoagulation related bleeding complications in the patient has led to the development of numerous strategies; the safest from a bleeding standpoint being anticoagulant-free hemodialysis.

Streamline® bloodlines (Medisystems® Corporation, Lawrence, MA) are designed to eliminate blood-air contact. A pressure pod measures arterial and venous pressures without any blood-air contact. The venous chamber is run without an air gap. It is also designed so that blood flows in a circular vortex manner. This airless system is thought to provide several benefits: improved dialysis efficiency and blood flow rates, reduced heparin use and clotting rates.

The goal of this study was to prospectively examine the Streamline® airless tubing system in an inpatient setting and its association with clotting rates, and dialysis efficiency.

Conditions

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End Stage Renal Failure on Dialysis Complication of Dialysis Blood Coagulation Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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General Care Cohort

The group included adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit. This was an observational study, with no interventions.

No interventions assigned to this group

Critical Care Cohort

The group included adult hospitalized patients requiring hemodialysis at the intensive care unit. This was an observational study, with no interventions.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All adult non-pregnant patients requiring inpatient hemodialysis at our center during the recruitment period until the target sample of dialysis sessions (n=1200) was reached.

Exclusion Criteria

* Pregnant females
* Children
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NxStage Medical

OTHER

Sponsor Role collaborator

Marie Hogan

OTHER

Sponsor Role lead

Responsible Party

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Marie Hogan

Associate Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Marie C. Hogan, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Hospital, Saint Marys Campus

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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Safadi S, Albright RC Jr, Dillon JJ, Williams AW, Alahdab F, Brown JK, Severson AL, Kremers WK, Ryan MA, Hogan MC. Prospective Study of Routine Heparin Avoidance Hemodialysis in a Tertiary Acute Care Inpatient Practice. Kidney Int Rep. 2017 Mar 16;2(4):695-704. doi: 10.1016/j.ekir.2017.03.003. eCollection 2017 Jul.

Reference Type RESULT
PMID: 29142987 (View on PubMed)

Related Links

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Other Identifiers

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13-003161

Identifier Type: -

Identifier Source: org_study_id

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