Trial Outcomes & Findings for Conventional Hemodialysis vs. Short Daily Hemodialysis (6 Days / Week) and Mechanisms of Blood Pressure Control (NCT NCT00759967)
NCT ID: NCT00759967
Last Updated: 2017-08-04
Results Overview
The average of 2 measurements taken pre each dialysis session in the third month of treatment were compared when the patients were on conventional hemodialysis compared to short daily hemodialysis. SBP was taken in accordance with guidelines from the Canadian Hypertension Society
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Average of the last month of the 3 month intervention
Results posted on
2017-08-04
Participant Flow
22 patients were recruited from the hemodialysis (HD) units of the Ottawa Hospital. 3 patients withdrew prior to randomization. 19 patients complete the conventional arm of the study, 2 patients withdrew during the short daily HD arm - they are included in the intention to treat analysis
There was a 3 month run in phase in which blood pressure was optimized prior to randomization. The 3 patients who were not randomized - 1) withdrew consent, he did not want his blood pressure taken routinely in dialysis, 2) one patient had concerns about medications being removed during daily dialysis that could not be reconciled, 3) screen failure
Participant milestones
| Measure |
Conventional Hemodialysis First, Then Short Daily Hemodialysis
After a 3 month run-in period patients who are randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. BP was monitored according to the Canadian hypertension guidelines both pre and post each dialysis session. Antihypertensive medication were adjusted accordingly to maintain BP within the guidelines. At the end of this 3 moth period, extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
In this group 10 participants started and completed the first intervention: Conventional Hemodialysis first (Period Table 1; Left Column). These 10 participants then started the second intervention: Short Daily Hemodialysis (Period Table 2: Left Column), of which 8 participants completed the Short Daily Hemodialysis.
|
Short Daily Hemodialysis First, Then Conventional Hemodialysis
After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). Blood pressure was monitored according to the Canadian hypertension guidelines both pre and post each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 month period, extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
In this group 9 participants started and completed the first intervention: Short Daily Hemodialysis first (Period Table 1: Right Column). These 9 participants then started the second intervention: Conventional Hemodialysis (Period Table 2: Right Column). All 9 participants finished conventional dialysis.
|
|---|---|---|
|
First Intervention
STARTED
|
10
|
9
|
|
First Intervention
COMPLETED
|
10
|
9
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
10
|
9
|
|
Second Intervention
COMPLETED
|
8
|
9
|
|
Second Intervention
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Conventional Hemodialysis vs. Short Daily Hemodialysis (6 Days / Week) and Mechanisms of Blood Pressure Control
Baseline characteristics by cohort
| Measure |
All Participants
n=19 Participants
All patients in the study were randomized after the 3 month run in phase to either Conventional HD or Short Daily HD for 3 months and then crossed over to the other treatment arm for 3 months
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 13 • n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Region of Enrollment
Canada
|
19 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Average of the last month of the 3 month interventionThe average of 2 measurements taken pre each dialysis session in the third month of treatment were compared when the patients were on conventional hemodialysis compared to short daily hemodialysis. SBP was taken in accordance with guidelines from the Canadian Hypertension Society
Outcome measures
| Measure |
Short Daily Hemodialysis
n=19 Participants
After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of the 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
|
Conventional Hemodialysis
n=19 Participants
After a 3 month run-in period patients randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
|
|---|---|---|
|
Mean Systolic Blood Pressure Over the Third Month of Each Treatment Arm
|
139 mm Hg
Standard Deviation 14
|
142 mm Hg
Standard Deviation 17
|
SECONDARY outcome
Timeframe: once the final participant has completed all intervention procedures, approx. 3 monthsThe extracellular fluid volume will be measured using bioelectrical impedance to determine if the mechanism by which short daily hemodialysis is associated with an improvement in blood pressure control is secondary to changes in extracellular fluid volume.
Outcome measures
| Measure |
Short Daily Hemodialysis
n=19 Participants
After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of the 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
|
Conventional Hemodialysis
n=19 Participants
After a 3 month run-in period patients randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
|
|---|---|---|
|
To Determine if the Mechanism by Which Short Daily Hemodialysis is Associated With Changes in Extracellular Fluid Volume
|
15.4 Litres
Standard Deviation 2.8
|
15.2 Litres
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: once the last participant has completed run in phase and after randomization, approx. 3 monthsSerum phosphate values from the end of the three month run in phase and after randomization used to measure metabolic homeostasis
Outcome measures
| Measure |
Short Daily Hemodialysis
n=19 Participants
After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of the 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
|
Conventional Hemodialysis
n=19 Participants
After a 3 month run-in period patients randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
|
|---|---|---|
|
To Determine if Short Daily Hemodialysis, Compared to Conventional Hemodialysis Maintains Metabolic Homeostasis
Serum Phosphate at end of 3 month run-in phase
|
1.61 mmol/Litre
Standard Deviation 0.53
|
1.61 mmol/Litre
Standard Deviation 0.53
|
|
To Determine if Short Daily Hemodialysis, Compared to Conventional Hemodialysis Maintains Metabolic Homeostasis
Serum phosphate after randomization
|
1.58 mmol/Litre
Standard Deviation 0.41
|
1.82 mmol/Litre
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: once the final participant has completed all intervention procedures, approx. 3 monthsOutcome measures
| Measure |
Short Daily Hemodialysis
n=12 Participants
After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of the 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
|
Conventional Hemodialysis
n=12 Participants
After a 3 month run-in period patients randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
|
|---|---|---|
|
To Determine if the Enhance Control of Blood Pressure With Daily Hemodialysis Compare to Conventional Hemodialysis is Associated With a Reduction in Oxidative Stress.
TBARS Baseline
|
2.3 mmol/ml MDA equivalent
Interval 1.9 to 2.9
|
2.3 mmol/ml MDA equivalent
Interval 1.9 to 2.9
|
|
To Determine if the Enhance Control of Blood Pressure With Daily Hemodialysis Compare to Conventional Hemodialysis is Associated With a Reduction in Oxidative Stress.
TBARS After Randomization
|
2.0 mmol/ml MDA equivalent
Interval 1.7 to 3.1
|
2.4 mmol/ml MDA equivalent
Interval 1.8 to 3.5
|
SECONDARY outcome
Timeframe: at study completionPopulation: The trial did not include a questionnaire regarding modality preference as originally planned
each participant will complete a questionaire regarding modality preference
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: once the final participant has completed all intervention procedures, approx. 3 monthsOutcome measures
| Measure |
Short Daily Hemodialysis
n=12 Participants
After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of the 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
|
Conventional Hemodialysis
n=12 Participants
After a 3 month run-in period patients randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
|
|---|---|---|
|
To Determine if the Enhance Control of Blood Pressure With Daily Hemodialysis Compare to Conventional Hemodialysis is Associated With a Reduction in Markers of Inflammation
IL-6 Baseline
|
1.55 pg/mL
Interval 1.04 to 3.26
|
1.55 pg/mL
Interval 1.04 to 3.26
|
|
To Determine if the Enhance Control of Blood Pressure With Daily Hemodialysis Compare to Conventional Hemodialysis is Associated With a Reduction in Markers of Inflammation
IL-6 After Randomization
|
1.52 pg/mL
Interval 0.95 to 3.3
|
1.45 pg/mL
Interval 0.65 to 3.08
|
Adverse Events
Short Daily Hemodialysis
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Hemodialysis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Short Daily Hemodialysis
n=19 participants at risk
After a 3 month run-in period patients who are randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication wer adjusted accordingly to maintain BP within the guidelines.At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress will be collected.
|
Conventional Hemodialysis
n=19 participants at risk
After a 3 month run-in period patients who were randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines.At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
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|---|---|---|
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Cardiac disorders
Hospitalization for congestive heart failure
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Deborah Zimmerman
Ottawa Hospital Research Institute
Phone: 613-738-8400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place