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Completed

NCT Number: NCT04188353

Effect of Intravenous Administration of Mannitol on ONSD in Patients With Raised ICP

Osmotherapy with mannitol has been a common practice in patients with raised ICP. Monitoring its effect on ICP can be performed invasively and non-invasively. Due to a validated correlation between invasive ICP monitoring and ONSD measurement, it can be a tool to monitor acute and long term effects of osmotherapy non-invasively on ICP. This study examines the acute changes in sonographically measured ONSD brought about by the administration of mannitol. This can correlate with the changes in ICP in such patients and can be utilized as a tool for decision making/ point-of-care utility.

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Key information

Conditions

Raised Intracranial Pressure Brain Diseases Central Nervous System Diseases Intracranial Hypertension Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maharajgunj Medical Campus

Kathmandu, Bagmati, 44600, Nepal

About this study

This is a prospective cohort based observational study including 40 patients admitted in the adult ICU at our center diagnosed as either a case of TBI/ acute stroke/ intracranial hemorrhages with a mean screening ONSD of more than 5mm under mannitol osmotherapy. ONSD were measured by a high frequency linear array probe (>10 Hz) at the time of screening. Mannitol was then administered at doses prescribed by the treating physician over 20-30 minutes via a dedicated intravenous line. ONSDs were measured again at 30, 60 and 120 minutes after completion of administration of mannitol. Demographic data, baseline ventilator parameters of patients on mechanical ventilation, GCS and mean arterial pressure at each time points were recorded. Comparison of variables at these time points were made.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 18 years
  • diagnosed as a case of TBI/ acute stroke/ intracranial hemorrhages
  • screening mean ONSD > 5 mm
  • under osmotherapy with mannitol in standard doses (0.25 - 1 gm/kg)

Exclusion criteria

  • baseline ocular pathology like tumors, Graves' disease and sarcoidosis
  • previous ocular surgery
  • Decompressive cranial surgery

Treatment and study plan

Optic nerve sheath diameter measurement

Device

ONSD measurements done at screening (T1), 30 minutes after mannitol infusion (T2), 60 minutes (T3) and 120 minutes (T4)

Other names: ONSD

Mannitol

Drug

Mannitol at dose of 0.25 to 1 gm/kg over 20 minutes via a dedicated IV line

Other names: Osmotherapy

Primary outcomes

  1. optic nerve sheath diameter at 30, 60 and 120 minutes after mannitol administration

    Time frame: 30, 60 and 120 minutes

    Change in optic nerve sheath diameter (ONSD)

Secondary outcomes

  1. Correlation between change in ONSD and Mean arterial pressure

    Time frame: 30, 60, and 120 minutes

    Correlation with change in ONSD and Mean arterial pressure

  2. Correlation between dose and change in ONSD

    Time frame: 30, 60 and 120 minutes

    Dose subgroups of <0.5gm/kg and >/= 0.5 gm/kg were compared and the correlated with changes in ONSD.

Other outcomes

  1. Comparison of ONSD values among ventilated and non-ventilated patients

    Time frame: 30, 60 and 120 minutes

    Comparison of ONSD values among ventilated and non-ventilated patients at 30,60 and 120 minutes

Sponsors and collaborators

Lead sponsor

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Other

Registry information

Official study title

Effect of Intravenous Administration of 20% Mannitol on the Optic Nerve Sheath Diameter(ONSD) in Patients With Raised Intracranial Pressure

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 5, 2019
Registry last updated
Dec 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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