Trial Outcomes & Findings for Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients (NCT NCT02145260)
NCT ID: NCT02145260
Last Updated: 2022-10-31
Results Overview
Pre-dialysis SBP minus lowest intra-dialytic SBP. The data table reflect the change in systolic blood pressured (SBP) assessed at up to 6 HD sessions, where the change for each session was calculated as the pre-SBP minus the lowest SBP (during the session), and the change values from the multiple sessions were then averaged for a participant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
144 participants
Primary outcome timeframe
Average decline in systolic blood pressure will be measured up to a maximum of six inpatient HD sessions, occurring over a two-week time period
Results posted on
2022-10-31
Participant Flow
3 patients in the lower dialysate sodium arm and 2 patients in the higher dialysate sodium arm were discharged prior to the first study session.
Participant milestones
| Measure |
Lower Dialysate Sodium
Dialysate sodium concentration of 138 mmol/L
Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate): A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)
|
Higher Dialysate Sodium
Dialysate sodium concentration of 142 mmol/L
Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate): A higher dialysate sodium will be used in the experimental arm (142 mmol/L)
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
70
|
|
Overall Study
COMPLETED
|
69
|
70
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients
Baseline characteristics by cohort
| Measure |
Lower Dialysate Sodium
n=69 Participants
Dialysate sodium concentration of 138 mmol/L
Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate): A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)
|
Higher Dialysate Sodium
n=70 Participants
Dialysate sodium concentration of 142 mmol/L
Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate): A higher dialysate sodium will be used in the experimental arm (142 mmol/L)
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 14 • n=5 Participants
|
58 years
STANDARD_DEVIATION 15 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
79 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=5 Participants
|
70 participants
n=7 Participants
|
139 participants
n=5 Participants
|
|
Diabetes
|
36 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Average decline in systolic blood pressure will be measured up to a maximum of six inpatient HD sessions, occurring over a two-week time periodPre-dialysis SBP minus lowest intra-dialytic SBP. The data table reflect the change in systolic blood pressured (SBP) assessed at up to 6 HD sessions, where the change for each session was calculated as the pre-SBP minus the lowest SBP (during the session), and the change values from the multiple sessions were then averaged for a participant.
Outcome measures
| Measure |
Lower Dialysate Sodium
n=69 Participants
Dialysate sodium concentration of 138 mmol/L
Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate): A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)
|
Higher Dialysate Sodium
n=70 Participants
Dialysate sodium concentration of 142 mmol/L
Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate): A higher dialysate sodium will be used in the experimental arm (142 mmol/L)
|
|---|---|---|
|
Change in Intra-dialytic Decline in Systolic Blood Pressure
|
26 mm Hg
Standard Deviation 16
|
23 mm Hg
Standard Deviation 16
|
SECONDARY outcome
Timeframe: The change in pre-dialysis high sensitivity troponin I concentrations will be measured between the first and second inpatient hemodialysis sessions, occuring over a period of three daysPopulation: No measured due to sample storage issues
Cardiac injury biomarkers
Outcome measures
Outcome data not reported
Adverse Events
Lower Dialysate Sodium
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Higher Dialysate Sodium
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lower Dialysate Sodium
n=69 participants at risk
Dialysate sodium concentration of 138 mmol/L
Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate): A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)
|
Higher Dialysate Sodium
n=70 participants at risk
Dialysate sodium concentration of 142 mmol/L
Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate): A higher dialysate sodium will be used in the experimental arm (142 mmol/L)
|
|---|---|---|
|
Cardiac disorders
NSTEMI non-ST segment elevation myocardial infarction
|
1.4%
1/69 • Number of events 1 • From randomization to maximum of 6 inpatient study sessions (two-week period)
|
0.00%
0/70 • From randomization to maximum of 6 inpatient study sessions (two-week period)
|
|
Blood and lymphatic system disorders
post-operative bleed
|
0.00%
0/69 • From randomization to maximum of 6 inpatient study sessions (two-week period)
|
1.4%
1/70 • Number of events 1 • From randomization to maximum of 6 inpatient study sessions (two-week period)
|
Other adverse events
| Measure |
Lower Dialysate Sodium
n=69 participants at risk
Dialysate sodium concentration of 138 mmol/L
Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate): A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)
|
Higher Dialysate Sodium
n=70 participants at risk
Dialysate sodium concentration of 142 mmol/L
Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate): A higher dialysate sodium will be used in the experimental arm (142 mmol/L)
|
|---|---|---|
|
Cardiac disorders
Hypotension
|
13.0%
9/69 • Number of events 9 • From randomization to maximum of 6 inpatient study sessions (two-week period)
|
8.6%
6/70 • Number of events 7 • From randomization to maximum of 6 inpatient study sessions (two-week period)
|
|
Cardiac disorders
Hypertension (>180 mmHg)
|
4.3%
3/69 • Number of events 3 • From randomization to maximum of 6 inpatient study sessions (two-week period)
|
10.0%
7/70 • Number of events 7 • From randomization to maximum of 6 inpatient study sessions (two-week period)
|
|
Cardiac disorders
Chest pain/myocardial infarction
|
5.8%
4/69 • Number of events 4 • From randomization to maximum of 6 inpatient study sessions (two-week period)
|
1.4%
1/70 • Number of events 1 • From randomization to maximum of 6 inpatient study sessions (two-week period)
|
|
Musculoskeletal and connective tissue disorders
Cramping
|
10.1%
7/69 • Number of events 10 • From randomization to maximum of 6 inpatient study sessions (two-week period)
|
8.6%
6/70 • Number of events 8 • From randomization to maximum of 6 inpatient study sessions (two-week period)
|
|
Nervous system disorders
Other pain
|
7.2%
5/69 • Number of events 8 • From randomization to maximum of 6 inpatient study sessions (two-week period)
|
5.7%
4/70 • Number of events 6 • From randomization to maximum of 6 inpatient study sessions (two-week period)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place