NCT04928040

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

June 22, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2022

Completed
Last Updated

January 31, 2022

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

June 9, 2021

Last Update Submit

January 16, 2022

Conditions

Fluid ChallengeIncreased Intracranial Pressure

Keywords

optic nerve sheath diameter, fluid challenge

Outcome Measures

Primary Outcomes (1)

  • The change in intracranial pressure associated with the fluid challenge

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

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

Secondary Outcomes (1)

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

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

Study Arms (1)

Fluid challenge

EXPERIMENTAL

Fluid challenge effects on optic nerve sheath diameter

Diagnostic Test: Measurement of optic nerve sheath diameter

Interventions

Measurement of optic nerve sheath diameterDIAGNOSTIC_TEST

The fluid challenge effects of optic nerve sheath diameter

Fluid challenge

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs Universitesi

Atakent, Samsun, 55280, Turkey (Türkiye)

Location

Related Publications (5)

  • Hoste EA, Maitland K, Brudney CS, Mehta R, Vincent JL, Yates D, Kellum JA, Mythen MG, Shaw AD; ADQI XII Investigators Group. Four phases of intravenous fluid therapy: a conceptual model. Br J Anaesth. 2014 Nov;113(5):740-7. doi: 10.1093/bja/aeu300. Epub 2014 Sep 9.

    PMID: 25204700BACKGROUND

  • Cecconi M, Parsons AK, Rhodes A. What is a fluid challenge? Curr Opin Crit Care. 2011 Jun;17(3):290-5. doi: 10.1097/MCC.0b013e32834699cd.

    PMID: 21508838BACKGROUND

  • Rajajee V, Vanaman M, Fletcher JJ, Jacobs TL. Optic nerve ultrasound for the detection of raised intracranial pressure. Neurocrit Care. 2011 Dec;15(3):506-15. doi: 10.1007/s12028-011-9606-8.

    PMID: 21769456BACKGROUND

  • McGuire G, Crossley D, Richards J, Wong D. Effects of varying levels of positive end-expiratory pressure on intracranial pressure and cerebral perfusion pressure. Crit Care Med. 1997 Jun;25(6):1059-62. doi: 10.1097/00003246-199706000-00025.

    PMID: 9201061BACKGROUND

  • Komurcu O, Cicek E, Akyurt D, Kusderci HS, Dogru S, Koc K, Suren M. Reliability and validity of the Turkish form of intensive care nursing activities score. BMC Nurs. 2024 Nov 6;23(1):810. doi: 10.1186/s12912-024-02490-y.

    PMID: 39506784DERIVED

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • ozgur komurcu, 1

    zgrkom@gmail.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 16, 2021

Study Start

June 22, 2021

Primary Completion

January 1, 2022

Study Completion

January 16, 2022

Last Updated

January 31, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Primary and secondary study outcomes

Locations

TU(1)