Trial Outcomes & Findings for Effect of Dialysis Glucose Bath on Glycemic Control in Hemodialysis (HD) (NCT NCT01359904)

Results Overview

post intervention hemoglobin A1c levels

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

3 months

Results posted on

2017-03-21

Participant Flow

The recruitment occurred at 2 sites of McGill University Health Centre. The recruitment period was from June 1, 2011 to July 30, 2012.

Once the treating physician identified the potential subject, the potential subject was approached by the research assistant with a consent form. All patients were consented by the research assistant through a written consent form. Then the subject was randomly assigned to the standard or higher glucose dialysate groups.

Participant milestones

Participant milestones
Measure	High Dialysate Bath additive is put in the dialysate to increase the concentration of glucose to 10mmol/l	Standard Dialysate Glucose Concentration Standard 5.5 mmol/L dialysate glucose concentration.
Overall Study STARTED	15	19
Overall Study COMPLETED	14	19
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	High Dialysate Bath additive is put in the dialysate to increase the concentration of glucose to 10mmol/l	Standard Dialysate Glucose Concentration Standard 5.5 mmol/L dialysate glucose concentration.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Effect of Dialysis Glucose Bath on Glycemic Control in Hemodialysis (HD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Dialysate Bath n=15 Participants additive is put in the dialysate to increase the concentration of glucose to 10mmol/l	Standard Dialysate Glucose Concentration n=19 Participants Standard 5.5 mmol/L dialysate glucose concentration.	Total n=34 Participants Total of all reporting groups
Age, Continuous	73 years n=5 Participants	65 years n=7 Participants	71 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment Canada	15 participants n=5 Participants	19 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: We planned forty subjects to detect a difference in the mean change in the HbA1c from baseline to at the end of the study of 1% among the two dialysate concentration groups with a two-tailed t-test and variance of 1%, the required sample size will be 20 for each group with a power of 88% and alpha set at 0.05.

post intervention hemoglobin A1c levels

Outcome measures

Outcome measures
Measure	High Dialysate Bath n=14 Participants additive is put in the dialysate to increase the concentration of glucose to 10mmol/l High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution.	Standard Dialysate Glucose Concentration n=15 Participants Standard 5.5 mmol/L dialysate glucose concentration.
Hemoglobin A1c Levels	7.1 percent Interval 4.4 to 8.6	7.1 percent Interval 4.7 to 10.4

SECONDARY outcome

Timeframe: 3 months

Population: We planned forty subjects to detect a difference in the mean change in the HbA1c from baseline to at the end of the study of 1% among the two dialysate concentration groups with a two-tailed t-test and variance of 1%, the required sample size will be 20 for each group with a power of 88% and alpha set at 0.05.

record number of episodes during dialysis with serum glucose below 4 mmol/L by glucometer

Outcome measures

Outcome measures
Measure	High Dialysate Bath n=14 Participants additive is put in the dialysate to increase the concentration of glucose to 10mmol/l High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution.	Standard Dialysate Glucose Concentration n=19 Participants Standard 5.5 mmol/L dialysate glucose concentration.
Episodes of Hypoglycemia	2 episodes	10 episodes

SECONDARY outcome

Timeframe: 3 months

Hemoglobin A1c levels will be measured before the intervention and after to assess any difference in the value. The blood samples were taken prior to dialysis treatments mid-week for each subject at baseline and at the end of the study in both the control and intervention groups.

Outcome measures

Outcome measures
Measure	High Dialysate Bath n=14 Participants additive is put in the dialysate to increase the concentration of glucose to 10mmol/l High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution.	Standard Dialysate Glucose Concentration n=19 Participants Standard 5.5 mmol/L dialysate glucose concentration.
To Record the Effects of a Higher Dialysate Concentration of Glucose on Glycemic Control of Hemodialysis Patients With Type 2 Diabetes Mellitus by Measuring Serum Levels of Hemoglobin A1c.	0.3 percent Interval -2.2 to 2.6	-0.1 percent Interval -2.6 to 1.1

SECONDARY outcome

Timeframe: 3 months

In the two groups, we will measure the number of episodes of vascular access related infections ie. catheter, AV fistula or AV graft associated infections in the study period. The episode was defined as a diagnosis in the chart written by the nurse or physician with a prescription of antibiotics.

Outcome measures

Outcome measures
Measure	High Dialysate Bath n=14 Participants additive is put in the dialysate to increase the concentration of glucose to 10mmol/l High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution.	Standard Dialysate Glucose Concentration n=19 Participants Standard 5.5 mmol/L dialysate glucose concentration.
the Number of Infections Related to Vascular Access in Dialysis Among Those Who Receive a Higher Glucose Concentration in the Dialysate and Those Who Receive the Standard Concentration	4 episodes	3 episodes

Adverse Events

High Dialysate Bath

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Dialysate Glucose Concentration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sameena Iqbal

MUHC

Phone: 5149341934

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place