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

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ClinicalTrials.gov Identifier: NCT01520207
Recruitment Status : Active, not recruiting
First Posted : January 27, 2012
Results First Posted : October 19, 2017
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Intra-dialytic Hypotension Drug: Mannitol (20%) Drug: 0.9% saline Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
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.
Actual Study Start Date : May 2012
Primary Completion Date : July 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Mannitol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. Efficacy of Mannitol Administration in Reducing the Frequency of Intra-dialytic Hypotension (Decline in Systolic Blood Pressure) During the First Three Hemodialysis Initiation Sessions. [ Time Frame: First three hemodialysis sessions (5 days) ]
    SBP decline during first three sessions


Eligibility Criteria

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 Posted: January 27, 2012    Key Record Dates
Results First Posted: October 19, 2017
Last Update Posted: November 21, 2017
Last Verified: October 2017

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