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Mannitol - Potential Role in Hemodialysis Initiation for Reduction of Intra-dialytic Hypotension

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01520207
First Posted: January 27, 2012
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sushrut S Waikar, Brigham and Women's Hospital
  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 Phase
Intra-dialytic Hypotension Drug: Mannitol (20%) Drug: 0.9% saline Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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 Sushrut S Waikar, 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) ]
    BP decline during first three sessions


Enrollment: 52
Actual Study Start Date: May 2012
Estimated Study Completion Date: December 2017
Primary Completion Date: July 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520207


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
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

Responsible Party: Sushrut S Waikar, Associate Professor of Medicine, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01520207     History of Changes
First Submitted: January 25, 2012
First Posted: January 27, 2012
Results First Submitted: September 20, 2017
Results First Posted: October 19, 2017
Last Update Posted: October 19, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs