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CompletedNCT03161977Updated Jul 31, 2017

The Effect of Mannitol on the Serum Potassium During Craniotomy

An observational study in Mannitol Adverse Reaction and Hyperkalemia, sponsored by The Affiliated Hospital of Xuzhou Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-07-31.

Sponsored by The Affiliated Hospital of Xuzhou Medical University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Mannitol Adverse Reaction
  • Hyperkalemia

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03

In context

Hyperkalemia

124 studies on the registry are indexed under Hyperkalemia; 25 are open to participants now.

This study's enrollment of 30 is below the median of 270 across 30 observational studies indexed under Hyperkalemia.

Browse Hyperkalemia studies →

Lead sponsor

The Affiliated Hospital of Xuzhou Medical University is the lead sponsor of 70 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients who are received craniotomy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • Mannitol

    Mannitol was intravenous infused within 15-20 mins when drilling skull

    Other: Mannitol

Interventions

  • OtherMannitol

    Mannitol was intravenous infused within 15-20 mins when drilling skull

06

What researchers measure

Primary outcomes

  1. the concentration of serum potassium

    measured by arterial blood gas analysis

    Time frame: two hours within infusioning mannitol

07

Study locations

1 site
  • The Affiliated Hospital of Xuzhou Medical University
    Xuzhou, Jiangsu 221000, China
08

References and documents

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 23354336 ↗
  • Maas 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 9202767 ↗
  • The 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 10937888 ↗
  • Fanous 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 27086258 ↗
  • Better 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 9328926 ↗
  • Palma 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 17019386 ↗
  • Rozet 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 18073543 ↗
  • Seto 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 11046231 ↗
  • WINTERS 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 14149918 ↗
  • Stewart PA. Modern quantitative acid-base chemistry. Can J Physiol Pharmacol. 1983 Dec;61(12):1444-61. doi: 10.1139/y83-207. PubMed 6423247 ↗
  • Manninen 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 3117392 ↗
  • Hirota 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 ↗

Individual participant data

Plan to share: No — IPD will be available when this trial is finished and the article have been published

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2017 to primary completion in Jun 2017, 5 months.

Of 19 observational studies under Hyperkalemia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 27. This study's 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 11, 2017
First posted
May 22, 2017
StartActual
Jan 1, 2017
Primary completionActual
Jun 1, 2017
CompletionActual
Jun 1, 2017
Last update
Jul 31, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03161977
Lead sponsor
The Affiliated Hospital of Xuzhou Medical University
Responsible party
Sponsor
First posted
May 22, 2017
Start date
Jan 1, 2017
Primary completion
Jun 1, 2017
Completion
Jun 1, 2017
Last update
Jul 31, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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