Mannitol Adverse ReactionNCT03161977
The Effect of Mannitol on the Serum Potassium During Craniotomy
An observational study of Mannitol Adverse Reaction and Hyperkalemia, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
This is an observational study designed to research the effect of mannitol on the concentration of intraoperative serum potassium in patients undergoing craniotomy, and to guide the safe use of mannitol during craniotomy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mannitol Adverse Reaction, Hyperkalemia
- What is being tested?
- Mannitol
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 1 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who are received craniotomy
Who may be able to join
- age 18 to 70
- American Society of Anesthesiologists physical status I to II
- liver and kidney function is normal
- preoperative concentration of serum potassium was from 3.5 to 5.5 mmol/L
Who cannot join
- history or presence of congestive heart failure (New York Heart Association class III to IV)
- history or presence of renal failure(diabetes insipidus, or syndrome of inappropriate antidiuretic hormone secretion)
- intraoperative blood transfusion
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
About this study
Official title: The Effect of Mannitol on Intraoperative Serum Potassium in Patients Undergoing Craniotomy：an Observational Study
This is an observational study designed to research the effect of mannitol on the concentration of intraoperative serum potassium in patients undergoing craniotomy, and to guide the safe use of mannitol during craniotomy.
Read the detailed description
Patients were assigned to receive 20% mannitol (1g/kg) solution administered intravenously 15-20 minutes at the time of drilling skull.The serum potassium was measured by arterial blood gas analysis before infusion (T0), infusion finished (T1), 15min (T2), 30min (T3), 60min (T4) and 120min (T5) after infusion.
- Conditions
- Mannitol Adverse Reaction, Hyperkalemia
- Being tested
- Mannitol
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MannitolOther
Mannitol was intravenous infused within 15-20 mins when drilling skull
| Study group | Role | What they receive |
|---|---|---|
| Mannitol | Mannitol was intravenous infused within 15-20 mins when drilling skull Receives: Other: Mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the concentration of serum potassium
measured by arterial blood gas analysis
Measured: two hours within infusioning mannitol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start1 Jan 2017
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Mannitol Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161977
- Sponsor's protocol ID
- XYFY-2017-011
- Status last verified
- Jan 2017
- First submitted
- 11 May 2017
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be available when this trial is finished and the article have been published
Publications
Quentin C, Charbonneau S, Moumdjian R, Lallo A, Bouthilier A, Fournier-Gosselin MP, Bojanowski M, Ruel M, Sylvestre MP, Girard F. A comparison of two doses of mannitol on brain relaxation during supratentorial brain tumor craniotomy: a randomized trial. Anesth Analg. 2013 Apr;116(4):862-8. doi: 10.1213/ANE.0b013e318282dc70. Epub 2013 Jan 25.
PubMed 23354336Maas AI, Dearden M, Teasdale GM, Braakman R, Cohadon F, Iannotti F, Karimi A, Lapierre F, Murray G, Ohman J, Persson L, Servadei F, Stocchetti N, Unterberg A. EBIC-guidelines for management of severe head injury in adults. European Brain Injury Consortium. Acta Neurochir (Wien). 1997;139(4):286-94. doi: 10.1007/BF01808823.
PubMed 9202767The Brain Trauma Foundation. The American Association of Neurological Surgeons. The Joint Section on Neurotrauma and Critical Care. Initial management. J Neurotrauma. 2000 Jun-Jul;17(6-7):463-9. doi: 10.1089/neu.2000.17.463.
PubMed 10937888Fanous AA, Tick RC, Gu EY, Fenstermaker RA. Life-Threatening Mannitol-Induced Hyperkalemia in Neurosurgical Patients. World Neurosurg. 2016 Jul;91:672.e5-9. doi: 10.1016/j.wneu.2016.04.021. Epub 2016 Apr 13.
PubMed 27086258Better OS, Rubinstein I, Winaver JM, Knochel JP. Mannitol therapy revisited (1940-1997). Kidney Int. 1997 Oct;52(4):886-94. doi: 10.1038/ki.1997.409. No abstract available.
PubMed 9328926Palma L, Bruni G, Fiaschi AI, Mariottini A. Passage of mannitol into the brain around gliomas: a potential cause of rebound phenomenon. A study on 21 patients. J Neurosurg Sci. 2006 Sep;50(3):63-6.
PubMed 17019386Rozet I, Tontisirin N, Muangman S, Vavilala MS, Souter MJ, Lee LA, Kincaid MS, Britz GW, Lam AM. Effect of equiosmolar solutions of mannitol versus hypertonic saline on intraoperative brain relaxation and electrolyte balance. Anesthesiology. 2007 Nov;107(5):697-704. doi: 10.1097/01.anes.0000286980.92759.94.
PubMed 18073543Seto A, Murakami M, Fukuyama H, Niijima K, Aoyama K, Takenaka I, Kadoya T. Ventricular tachycardia caused by hyperkalemia after administration of hypertonic mannitol. Anesthesiology. 2000 Nov;93(5):1359-61. doi: 10.1097/00000542-200011000-00036. No abstract available.
PubMed 11046231WINTERS RW, SCAGLIONE PR, NAHAS GG, VEROSKY M. THE MECHANISM OF ACIDOSIS PRODUCED BY HYPEROSMOTIC INFUSIONS. J Clin Invest. 1964 Apr;43(4):647-58. doi: 10.1172/JCI104950. No abstract available.
PubMed 14149918Stewart PA. Modern quantitative acid-base chemistry. Can J Physiol Pharmacol. 1983 Dec;61(12):1444-61. doi: 10.1139/y83-207.
PubMed 6423247Manninen PH, Lam AM, Gelb AW, Brown SC. The effect of high-dose mannitol on serum and urine electrolytes and osmolality in neurosurgical patients. Can J Anaesth. 1987 Sep;34(5):442-6. doi: 10.1007/BF03014345.
PubMed 3117392Hirota K, Hara T, Hosoi S, Sasaki Y, Hara Y, Adachi T. Two cases of hyperkalemia after administration of hypertonic mannitol during craniotomy. J Anesth. 2005;19(1):75-7. doi: 10.1007/s00540-004-0270-4.
PubMed 15674521
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mannitol on Intraoperative Serum Potassium in Patients Undergoing Craniotomy：an Observational Study
- ClinicalTrials.gov ID
- NCT03161977
- Acronym / sponsor ID
- XYFY-2017-011
- Conditions
- Mannitol Adverse Reaction, Hyperkalemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study designed to research the effect of mannitol on the concentration of intraoperative serum potassium in patients undergoing craniotomy, and to guide the safe use of mannitol during craniotomy.
Detailed description
Patients were assigned to receive 20% mannitol (1g/kg) solution administered intravenously 15-20 minutes at the time of drilling skull.The serum potassium was measured by arterial blood gas analysis before infusion (T0), infusion finished (T1), 15min (T2), 30min (T3), 60min (T4) and 120min (T5) after infusion.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mannitol | – | Other: MannitolMannitol was intravenous infused within 15-20 mins when drilling skull |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who are received craniotomy
Key inclusion criteria (4 listed)
- age 18 to 70
- American Society of Anesthesiologists physical status I to II
- liver and kidney function is normal
- preoperative concentration of serum potassium was from 3.5 to 5.5 mmol/L
Key exclusion criteria (3 listed)
- history or presence of congestive heart failure (New York Heart Association class III to IV)
- history or presence of renal failure(diabetes insipidus, or syndrome of inappropriate antidiuretic hormone secretion)
- intraoperative blood transfusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MannitolMannitol was intravenous infused within 15-20 mins when drilling skull | Other | Mannitol |
Primary outcome
the concentration of serum potassium
Time frame: two hours within infusioning mannitol
measured by arterial blood gas analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
- Background: PubMed 23354336Quentin C, Charbonneau S, Moumdjian R, Lallo A, Bouthilier A, Fournier-Gosselin MP, Bojanowski M, Ruel M, Sylvestre MP, Girard F. A comparison of two doses of mannitol on brain relaxation during supratentorial brain tumor craniotomy: a randomized trial. Anesth Analg. 2013 Apr;116(4):862-8. doi: 10.1213/ANE.0b013e318282dc70. Epub 2013 Jan 25.
- Background: PubMed 9202767Maas AI, Dearden M, Teasdale GM, Braakman R, Cohadon F, Iannotti F, Karimi A, Lapierre F, Murray G, Ohman J, Persson L, Servadei F, Stocchetti N, Unterberg A. EBIC-guidelines for management of severe head injury in adults. European Brain Injury Consortium. Acta Neurochir (Wien). 1997;139(4):286-94. doi: 10.1007/BF01808823.
- Background: PubMed 10937888The Brain Trauma Foundation. The American Association of Neurological Surgeons. The Joint Section on Neurotrauma and Critical Care. Initial management. J Neurotrauma. 2000 Jun-Jul;17(6-7):463-9. doi: 10.1089/neu.2000.17.463.
- Background: PubMed 27086258Fanous AA, Tick RC, Gu EY, Fenstermaker RA. Life-Threatening Mannitol-Induced Hyperkalemia in Neurosurgical Patients. World Neurosurg. 2016 Jul;91:672.e5-9. doi: 10.1016/j.wneu.2016.04.021. Epub 2016 Apr 13.
- Background: PubMed 9328926Better OS, Rubinstein I, Winaver JM, Knochel JP. Mannitol therapy revisited (1940-1997). Kidney Int. 1997 Oct;52(4):886-94. doi: 10.1038/ki.1997.409. No abstract available.
- Background: PubMed 17019386Palma L, Bruni G, Fiaschi AI, Mariottini A. Passage of mannitol into the brain around gliomas: a potential cause of rebound phenomenon. A study on 21 patients. J Neurosurg Sci. 2006 Sep;50(3):63-6.
- Background: PubMed 18073543Rozet I, Tontisirin N, Muangman S, Vavilala MS, Souter MJ, Lee LA, Kincaid MS, Britz GW, Lam AM. Effect of equiosmolar solutions of mannitol versus hypertonic saline on intraoperative brain relaxation and electrolyte balance. Anesthesiology. 2007 Nov;107(5):697-704. doi: 10.1097/01.anes.0000286980.92759.94.
- Background: PubMed 11046231Seto A, Murakami M, Fukuyama H, Niijima K, Aoyama K, Takenaka I, Kadoya T. Ventricular tachycardia caused by hyperkalemia after administration of hypertonic mannitol. Anesthesiology. 2000 Nov;93(5):1359-61. doi: 10.1097/00000542-200011000-00036. No abstract available.
- Background: PubMed 14149918WINTERS RW, SCAGLIONE PR, NAHAS GG, VEROSKY M. THE MECHANISM OF ACIDOSIS PRODUCED BY HYPEROSMOTIC INFUSIONS. J Clin Invest. 1964 Apr;43(4):647-58. doi: 10.1172/JCI104950. No abstract available.
- Background: PubMed 6423247Stewart PA. Modern quantitative acid-base chemistry. Can J Physiol Pharmacol. 1983 Dec;61(12):1444-61. doi: 10.1139/y83-207.
- Background: PubMed 3117392Manninen PH, Lam AM, Gelb AW, Brown SC. The effect of high-dose mannitol on serum and urine electrolytes and osmolality in neurosurgical patients. Can J Anaesth. 1987 Sep;34(5):442-6. doi: 10.1007/BF03014345.
- Background: PubMed 15674521Hirota K, Hara T, Hosoi S, Sasaki Y, Hara Y, Adachi T. Two cases of hyperkalemia after administration of hypertonic mannitol during craniotomy. J Anesth. 2005;19(1):75-7. doi: 10.1007/s00540-004-0270-4.
- Individual participant dataSharing planned: No. IPD will be available when this trial is finished and the article have been published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mannitol Adverse Reaction and Hyperkalemia, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the concentration of serum potassium (time frame: two hours within infusioning mannitol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03161977, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2017; AzTrials last refreshed its copy on 6 Nov 2026.