Fluid ChallengeNCT04928040
Effect of Fluid Challenge on Intracranial Pressure
A study testing Measurement of optic nerve sheath diameter in people with Fluid Challenge and Increased Intracranial Pressure, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fluid Challenge, Increased Intracranial Pressure
- What is being tested?
- Measurement of optic nerve sheath diameter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jun 2021to 16 Jan 2022
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs Universitesi
Atakent, Samsun, 55280
About this study
Official title: Evaluation of Intracranial Pressure Change by Measuring Optic Nerve Sheath Diameter During Fluid Challenge
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).
Read the detailed description
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.
- Conditions
- Fluid Challenge, Increased Intracranial Pressure
- Being tested
- Measurement of optic nerve sheath diameter
- Keywords
- optic nerve sheath diameter, fluid challenge
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of optic nerve sheath diameterDiagnostic test
The fluid challenge effects of optic nerve sheath diameter
| Study group | Role | What they receive |
|---|---|---|
| Fluid challenge | Experimental | Fluid challenge effects on optic nerve sheath diameter Receives: Diagnostic Test: Measurement of optic nerve sheath diameter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in intracranial pressure associated with the fluid challenge
The change in intracranial pressure according to the optic nerve sheath diameter measurements.
Measured: 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
The fluid responsiveness associated with the change in optic nerve sheath diameter measurements
Measured: Before, at the end, and 30 min after the fluid challenge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start22 Jun 2021
- Primary completion1 Jan 2022
- Study completion16 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Fluid ChallengeStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgur Komurcu, Ondokuz Mayıs University
- Investigators
- ozgur komurcu, 1, Principal investigator, zgrkom@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928040
- Sponsor's protocol ID
- 2020/436
- Status last verified
- Jan 2022
- First submitted
- 9 Jun 2021
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Primary and secondary study outcomes
Publications
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.
PubMed 25204700Cecconi 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.
PubMed 21508838Rajajee 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.
PubMed 21769456McGuire 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.
PubMed 9201061Komurcu 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.
PubMed 39506784
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intracranial Pressure Change by Measuring Optic Nerve Sheath Diameter During Fluid Challenge
- ClinicalTrials.gov ID
- NCT04928040
- Acronym / sponsor ID
- 2020/436
- Conditions
- Fluid Challenge, Increased Intracranial Pressure
- Keywords
- optic nerve sheath diameter, fluid challenge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 16 Jan 2022 (actual)
- First posted
- 16 Jun 2021 (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.
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).
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluid challenge | Experimental | Diagnostic Test: Measurement of optic nerve sheath diameterFluid challenge effects on optic nerve sheath diameter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Measurement of optic nerve sheath diameterThe fluid challenge effects of optic nerve sheath diameter | Diagnostic test | Fluid challenge |
Primary outcome
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.
1 secondary outcome
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.
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 Jan 2022.
- Background: PubMed 25204700Hoste 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.
- Background: PubMed 21508838Cecconi 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.
- Background: PubMed 21769456Rajajee 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.
- Background: PubMed 9201061McGuire 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.
- Derived from this study: PubMed 39506784Komurcu 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.
- Individual participant dataSharing planned: No. Primary and secondary study outcomes
Related trials for Fluid Challenge
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Fluid Responsiveness in Laparoscopic Surgery: End-Expiratory Occlusion Test Versus Mini-Fluid Challenge
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Changes in Portal Vein Pulsatility Variability During a Tidal Volume Challenge Can Predict Fluid Tolerance
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RecruitingObservational study
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Hemodynamic Instability
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.
ozgur komurcu, 1 principal investigator
zgrkom@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of optic nerve sheath diameter in people with Fluid Challenge and Increased Intracranial Pressure, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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 Jan 2022. 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 Turkey (Türkiye). 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 change in intracranial pressure associated with the fluid challenge (time frame: Before, at the end, and 30 min after the fluid challenge.). 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 NCT04928040, which also lists 5 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 Jan 2022.