Mannitol - Potential Role in Hemodialysis Initiation for Reduction of Intra-dialytic Hypotension
This study is currently recruiting participants.
Verified February 2013 by Brigham and Women's Hospital
Sponsor:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Sushrut S Waikar, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01520207
First received: January 25, 2012
Last updated: February 14, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Intra-dialytic Hypotension |
Drug: Mannitol (20%) Drug: 0.9% saline |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| Official Title: | Pilot Study of Intravenous Mannitol During Hemodialysis Initiation to Reduce the Occurrence of Intra-dialytic Hypotension. |
Resource links provided by NLM:
Further study details as provided by Brigham and Women's Hospital:
Primary Outcome Measures:
- Determine the efficacy of mannitol administration in reducing the frequency of intra-dialytic hypotension during the first three hemodialysis initiation sessions. [ Time Frame: First three hemodialysis sessions (5 days) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine the effect of mannitol administration on the change in blood and urine biomarkers of acute kidney injury during the first three hemodialysis initiation sessions. [ Time Frame: First three hemodialysis sessions (5 days) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 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.
|
Drug: 0.9% saline
1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment
|
|
Active Comparator: 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.
|
Drug: Mannitol (20%)
0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520207
Contacts
| Contact: Sushrut S Waikar, MD, MPH | 617-732-8473 | swaikar@partners.org |
| Contact: Finnian R Mc Causland, MB, MMSc | 617-732-6432 | fmccausland@partners.org |
Locations
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: Sushrut S Waikar, MD MPH | |
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
| Principal Investigator: | Sushrut S Waikar, MD, MPH | Brigham and Women's Hospital, Harvard Medical School |
| Principal Investigator: | Finnian R Mc Causland, MB, MMSc | Brigham and Women's Hospital |
More Information
No publications provided
| Responsible Party: | Sushrut S Waikar, Assistant Professor of Medicine, Harvard Medical School, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01520207 History of Changes |
| Other Study ID Numbers: | NCT01520207 |
| Study First Received: | January 25, 2012 |
| Last Updated: | February 14, 2013 |
| Health Authority: | United States: Partners Institutional Review Board |
Additional relevant MeSH terms:
|
Hypotension Vascular Diseases Cardiovascular Diseases Mannitol Diuretics, Osmotic Diuretics |
Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013