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Completed

NCT Number: NCT04928040

Effect of Fluid Challenge on Intracranial Pressure

Fluid challenge is frequently used in fluid management of critically ill patients. Assessing whether there is a preload reserve that can be used to increase the stroke volume by delivering a small amount of fluid in a short period of time. Optimization of fluid therapy is very important in intensive care patients. Inappropriate fluid therapy can cause significant morbidity and even mortality. Increased intracranial pressure is one of these important complications. In the present study, we planned to evaluate the effect of a fluid challenge on intracranial pressure by measuring the optic nerve sheath diameter (ONSD).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayıs Universitesi

Atakent, Samsun, 55280, Turkey (Türkiye)

About this study

The fluid challenge is a simple volume resuscitation evaluation method that provides an indication of the patient's likelihood of benefiting from an increase in the intravenous fluid volume. Both the fluid challenge and fluid responsiveness are evaluated by interpreting the change in hemodynamic parameters after 500 mL of crystalloid (or 250 mL of colloid) solution is infused over 10-15 min. This is done in an attempt to regulate the fluid therapy of hemodynamically unstable patients in order to prevent fluid overload. In the present study, we aim to investigate the effect of the fluid challenge maneuver on intracranial pressure in ICU patients with hemodynamic instability through measuring the optic nerve sheath diameter by ultrasonography.

Patients in the intensive care unit undergoing a fluid challenge were included in this prospective observational study. A fluid challenge is defined as a 500 mL crystalloid infusion administered over 10 min, and fluid responsiveness is defined as a subsequent increase in stroke volume of at least 15%. The ONSD and hemodynamic variables will be measured by ultrasonography before (T0), at the end (T1), and 30 min after the fluid challenge (T2). The primary outcome of the study is the change in intracranial pressure associated with the fluid challenge, and the secondary outcome is the relationship between fluid responsiveness and the change in ONSD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with no known intracranial pathology.
  • Patients with systolic blood pressure < 90 mmHg
  • Patients with mean blood pressure < 65 mmHg
  • Patients with tachycardia (heart rate 100 beats/min)
  • Patients with mottled skin, oliguria (diuresis of less than 20 ml/hr or 0.5 ml/kg/hr for two hours), and acute renal failure.
  • Patients with arterial lactate concentration > 2 mmol/L

Exclusion criteria

  • Patients with known intracranial hypertension
  • Patients in the early postpartum period
  • Patients with severe mitral or aortic regurgitation
  • Patients with cardiac arrhythmia
  • Patients unable to be evaluated due to poor echogenicity

Treatment and study plan

Measurement of optic nerve sheath diameter

Diagnostic Test

The fluid challenge effects of optic nerve sheath diameter

Primary outcomes

  1. The change in intracranial pressure associated with the fluid challenge

    Time frame: Before, at the end, and 30 min after the fluid challenge.

    The change in intracranial pressure according to the optic nerve sheath diameter measurements.

Secondary outcomes

  1. The relationship between fluid responsiveness and the change in optic nerve sheath diameter

    Time frame: Before, at the end, and 30 min after the fluid challenge.

    The fluid responsiveness associated with the change in optic nerve sheath diameter measurements

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Evaluation of Intracranial Pressure Change by Measuring Optic Nerve Sheath Diameter During Fluid Challenge

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 16, 2021
Registry last updated
Jan 31, 2022

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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