Intra-dialytic Hypotension
Conditions
Brief summary
Kidney failure can result from a variety of conditions and can be temporary or permanent. Hemodialysis is available as a replacement treatment to perform the work that the kidneys normally do. However, the dialysis procedure can be associated with rapid changes in the composition of the blood - this may lead to changes in blood pressure and in turn reduced blood supply to important parts of the body. We aim to investigate if giving a medicine (called mannitol) during dialysis may be able to reduce the frequency of these low blood pressure events.
Interventions
DRUGMannitol (20%)
0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)
DRUG0.9% saline
1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Renal failure requiring intermittent hemodialysis initiation; adult patients aged over 18 years; written informed consent
Exclusion criteria
* Hyponatremia \<130 mmol/L; acute myocardial infarction or stroke in previous 7 days; cardiac transplant; ventricular arrhythmia; unstable angina; use of pressors/midodrine; enrollment in conflicting research study; institutionalized individuals; pregnancy; prisoners; documented allergy to mannitol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Mannitol Administration in Reducing the Frequency of Intra-dialytic Hypotension (Decline in Systolic Blood Pressure) During the First Three Hemodialysis Initiation Sessions. | First three hemodialysis sessions (5 days) | SBP decline during first three sessions |
Countries
United States
Participant flow
Recruitment details
July 2012 - Jul 2016
Participants by arm
| Arm | Count |
|---|---|
| Placebo Group: (0.9% Normal Saline) 0.9% saline will be administered (IV) during the hemodialysis session at 1.25mL/kg/hour (max 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.
0.9% saline: 1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment | 27 |
| Intervention: Intravenous Mannitol (20%) Mannitol will be administered (IV) during the hemodialysis session at a maximum rate of 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.
Mannitol (20%): 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session) | 25 |
| Total | 52 |
Baseline characteristics
| Characteristic | Placebo Group: (0.9% Normal Saline) | Intervention: Intravenous Mannitol (20%) | Total |
|---|---|---|---|
| Age, Continuous | 57.7 years STANDARD_DEVIATION 14.7 | 53.4 years STANDARD_DEVIATION 17.4 | 55.6 years STANDARD_DEVIATION 16 |
| Region of Enrollment United States | 27 participants | 25 participants | 52 participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Male | 14 Participants | 12 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 25 |
| other Total, other adverse events | 18 / 27 | 17 / 25 |
| serious Total, serious adverse events | 0 / 27 | 0 / 25 |
Outcome results
Primary
Efficacy of Mannitol Administration in Reducing the Frequency of Intra-dialytic Hypotension (Decline in Systolic Blood Pressure) During the First Three Hemodialysis Initiation Sessions.
SBP decline during first three sessions
Time frame: First three hemodialysis sessions (5 days)
Population: SBP decline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group: (0.9% Normal Saline) | Efficacy of Mannitol Administration in Reducing the Frequency of Intra-dialytic Hypotension (Decline in Systolic Blood Pressure) During the First Three Hemodialysis Initiation Sessions. | 19 mmHg | Standard Deviation 16 |
| Intervention: Intravenous Mannitol (20%) | Efficacy of Mannitol Administration in Reducing the Frequency of Intra-dialytic Hypotension (Decline in Systolic Blood Pressure) During the First Three Hemodialysis Initiation Sessions. | 15 mmHg | Standard Deviation 11 |