Phase 2
N=52
Mannitol - Potential Role in Hemodialysis Initiation for Reduction of Intra-dialytic Hypotension
Intra-dialytic Hypotension
Bottom Line
View on ClinicalTrials.gov: NCT01520207 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: 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. — 19; 15 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mannitol (20%) (Drug); 0.9% saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
19; 15 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01520207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.