Trial Outcomes & Findings for A Prospective Study of Airless Tubing in an Inpatient Acute Hemodialysis Unit in Hospitalized Patients (NCT NCT02086682)

NCT ID: NCT02086682

Last Updated: 2019-07-15

Results Overview

Each dialysis session was prospectively observed for Clotting of Extracorporeal Dialysis Circuit. Events were defined as interruption of hemodialysis session, loss of the hemodialysis circuit, or inability to return blood to the patient upon rinse back.

• Recruitment status: COMPLETED
• Target enrollment: 338 participants
• Primary outcome timeframe: During the dialysis session, approximately 211 minutes
• Results posted on: 2019-07-15

Participant Flow

338 patients were enrolled at the Mayo Clinic in Rochester, Minnesota from January 2014 to May 2015.

Participant milestones

Measure	General Care Cohort The group included adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit. This was an observational study, with no interventions.	Critical Care Cohort The group included adult hospitalized patients requiring hemodialysis at the intensive care unit. This was an observational study, with no interventions.
Overall Study STARTED	156	182
Overall Study COMPLETED	156	182
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	General Care Cohort n=156 Participants The group included adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit. This was an observational study, with no interventions.	Critical Care Cohort n=182 Participants The group included adult hospitalized patients requiring hemodialysis at the intensive care unit. This was an observational study, with no interventions.	Total n=338 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 16 • n=5 Participants	62 years STANDARD_DEVIATION 17 • n=7 Participants	62.5 years STANDARD_DEVIATION 16.5 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	67 Participants n=7 Participants	127 Participants n=5 Participants
Sex: Female, Male Male	96 Participants n=5 Participants	115 Participants n=7 Participants	211 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	133 Participants n=5 Participants	163 Participants n=7 Participants	296 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	156 participants n=5 Participants	182 participants n=7 Participants	338 participants n=5 Participants

PRIMARY outcome

Timeframe: During the dialysis session, approximately 211 minutes

Population: Units in the study referred to a dialysis session. A patient could have received dialysis more than once. Hence the number of patients (338) is less than the number of dialysis sessions (1200).

Each dialysis session was prospectively observed for Clotting of Extracorporeal Dialysis Circuit. Events were defined as interruption of hemodialysis session, loss of the hemodialysis circuit, or inability to return blood to the patient upon rinse back.

Outcome measures

Measure	General Care Cohort n=600 Dialysis Sessions The group included adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit. This was an observational study, with no interventions.	Critical Care Cohort n=600 Dialysis Sessions The group included adult hospitalized patients requiring hemodialysis at the intensive care unit. This was an observational study, with no interventions.
Clotting of Extracorporeal Dialysis Circuit	30 Clotting events	33 Clotting events

Adverse Events

General Care Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 31 deaths

Critical Care Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 40 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Marie Hogan

Mayo Clinic

Phone: 507-266 -1963

Email: Hogan.Marie@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place