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Mannitol

Generic Name
Mannitol
Brand Names
Aridol, Bronchitol, Cystosol, Osmitrol, Sag-M
Drug Type
Small Molecule
Chemical Formula
C6H14O6
CAS Number
69-65-8
Unique Ingredient Identifier
3OWL53L36A
Background

Mannitol is an osmotic diuretic that is metabolically inert in humans and occurs naturally, as a sugar or sugar alcohol, in fruits and vegetables. Mannitol elevates blood plasma osmolality, resulting in enhanced flow of water from tissues, including the brain and cerebrospinal fluid, into interstitial fluid and plasma. As a result, cerebral edema, elevated intracranial pressure, and cerebrospinal fluid volume and pressure may be reduced. Mannitol may also be used for the promotion of diuresis before irreversible renal failure becomes established; the promotion of urinary excretion of toxic substances; as an Antiglaucoma agent; and as a renal function diagnostic aid.

On October 30, 2020, mannitol was approved by the FDA as add-on maintenance therapy for the control of pulmonary symptoms associated with cystic fibrosis in adult patients and is currently marketed for this indication under the name BRONCHITOL® by Chiesi USA Inc.

Indication

Used for the promotion of diuresis before irreversible renal failure becomes established, the reduction of intracranial pressure, the treatment of cerebral edema, and the promotion of urinary excretion of toxic substances.

Mannitol is also indicated as add-on maintenance therapy for improving pulmonary function in cystic fibrosis patients aged 18 and over who have passed the BRONCHITOL tolerance test (BTT). It is recommended that patients take an orally inhaled short-acting bronchodilator 5-15 minutes prior to every inhaled mannitol dose.

Associated Conditions
Acute Renal Failure (ARF), Cystic Fibrosis (CF), Edema of the cerebrum, Increased Intra Ocular Pressure (IOP)
Associated Therapies
Bladder irrigation therapy

Inhaled Mannitol on Mucociliary Clearance in Moderate to Severe Cystic Fibrosis

Phase 4
Recruiting
Conditions
Cystic Fibrosis
Interventions
First Posted Date
2023-02-23
Last Posted Date
2024-07-29
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
25
Registration Number
NCT05740618
Locations
🇺🇸

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

Assessment of the Efficacy of Calcium Dobesilate vs. Placebo on SARS-CoV-2 Viral Load Amongst Outpatients With COVID-19.

Phase 2
Completed
Conditions
COVID-19 Virus Disease
Interventions
First Posted Date
2022-03-31
Last Posted Date
2024-02-28
Lead Sponsor
Hervé SPECHBACH
Target Recruit Count
74
Registration Number
NCT05305508
Locations
🇨🇭

Division and Department of Primary Care Medicine, Geneva University Hospitals, Geneva, Switzerland

Effect of Mannitol on Postreperfusion Syndrome During Living Donor Liver Transplant

Early Phase 1
Completed
Conditions
Liver Transplant Disorder
Interventions
Other: 0.9% normal saline
First Posted Date
2022-03-14
Last Posted Date
2023-01-18
Lead Sponsor
Ain Shams University
Target Recruit Count
60
Registration Number
NCT05277623
Locations
🇪🇬

Medicine Ain Shams University, Cairo, Egypt

A Study of Two Formulations (Both Refrigerated and Room Temperature) Using an Autoinjector Device in Healthy Participants

Phase 1
Completed
Conditions
Healthy Participants
Interventions
Drug: Citrate buffer
Device: Prefilled Autoinjector
First Posted Date
2021-12-13
Last Posted Date
2022-01-13
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
44
Registration Number
NCT05154968
Locations
🇨🇦

Syneos Health, Québec, Canada

Retrograde Autologous Priming and Mannitol for Reducing Hemodilution in Cardiac Surgery

Phase 3
Withdrawn
Conditions
Coronary Artery Disease
Fluid Overload
Hemodilution
Interventions
Procedure: Retrograde autologous priming
Procedure: Conventional Priming
First Posted Date
2021-05-03
Last Posted Date
2023-02-28
Lead Sponsor
Hamilton Health Sciences Corporation
Registration Number
NCT04870073
Locations
🇨🇦

Hamilton General Hospital, Hamilton, Ontario, Canada

Mannitol Use During Cadaveric Kidney Transplantation

Not Applicable
Conditions
Renal Dialysis
Interventions
Drug: Saline
First Posted Date
2021-01-12
Last Posted Date
2021-01-22
Lead Sponsor
Rabin Medical Center
Target Recruit Count
32
Registration Number
NCT04705402

Study to Gather Information on the Acceptability of a New Flavor System With Increasing Levels of 2, 4, 6 g or Higher of Mannitol for PEG 3350 in Subjects Having Infrequent Bowel Movements.

Phase 4
Completed
Conditions
Constipation
Interventions
Drug: Polyethylene glycol (MiraLAX, BAY81-8430)
First Posted Date
2020-09-01
Last Posted Date
2020-11-12
Lead Sponsor
Bayer
Target Recruit Count
50
Registration Number
NCT04534465
Locations
🇺🇸

Merck Consumer Center, Memphis, Tennessee, United States

Sodium Lactate and Brain Relaxation (LSD)

Phase 3
Completed
Conditions
Sodium Lactate
Intracranial Hypertension
Brain Relaxation
Interventions
First Posted Date
2020-07-28
Last Posted Date
2023-09-13
Lead Sponsor
Centre Hospitalier Universitaire de Besancon
Target Recruit Count
50
Registration Number
NCT04488874
Locations
🇫🇷

CHU de Besançon, Besancon, France

MAnnitol for Blood Pressure Stability in HemoDialysis (MAP-HD)

Phase 2
Recruiting
Conditions
Hemodialysis Complication
Hemodynamic Instability
Interventions
Drug: 0.9% saline
First Posted Date
2020-06-11
Last Posted Date
2024-02-14
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
30
Registration Number
NCT04428372
Locations
🇺🇸

Brigham and Women's, Boston, Massachusetts, United States

Effect of AD128 to Treat Obstructive Sleep Apnea

Phase 2
Completed
Conditions
Sleep Apnea, Obstructive
Interventions
First Posted Date
2020-05-19
Last Posted Date
2021-08-06
Lead Sponsor
Raphael Heinzer
Target Recruit Count
15
Registration Number
NCT04394143
Locations
🇨🇭

Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

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