An interventional study of Standard care (control group) and US-guided fluid management (active group) in Traumatic Brain Injury, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-06-01.
Sponsored by Mansoura University · Not applicable, Interventional, and Diagnostic
Traumatic brain injury (TBI) is a leading cause of death and disability in trauma patients. As the primary injury cannot be reversed, management strategies must focus on preventing secondary injury by avoiding hypotension and hypoxia and maintaining appropriate cerebral perfusion pressure (CPP), which is a surrogate for cerebral blood flow (CBF). The goal should be euvolemia and avoidance of hypotension. The assessment of a patient's body fluid status is a challenging task for modern clinicians.
The use of Ultrasonography to assess body fluids has numerous advantages. The concept of using lung ultrasound for monitoring the patient is one of the major innovations that emerged from recent studies. Pulmonary congestion may be semiquantified using lung ultrasound and deciding how the patient tolerates fluid. Inferior vena cava (IVC) sonography and point-of-care ultrasound (POCUS) has become widely used as a tool to help clinicians prescribe fluid therapy. Common POCUS applications that serve as guides to fluid administration rely on assessments of the inferior vena cava to estimate preload and lung ultrasound to identify the early presence of extravascular lung water and avoid fluid over resuscitation In this study we will use the measurements of both lung and IVC together to guide fluid dosage in critically ill patients with TBI. We will also use ONSD as a mirror for intra-cranial pressure (ICP).
The aim of this study is to detect the effectiveness of using IVC and lung ultrasound as bedside tools to ensure euvolemia in patients with traumatic brain injuries
Positive fluid balances have been associated with (angiographic) vasospasm, longer hospital length of stay and poor functional outcomes The assessment of a patient's body fluid status is a challenging task for modern clinicians. Currently, the most accurate method to guide fluid administration decisions uses "dynamic" measures that estimate the change in cardiac output that would occur in response to a fluid bolus. Unfortunately, their use remains limited due to required technical expertise, costly equipment, or applicability in only a subset of patients. Alternatively, point-of-care ultrasound (POCUS) has become widely used as a tool to help clinicians prescribe fluid therapy.
International recommendations suggest that the inferior vena cava (IVC) can be assessed to estimate the pressure in the right atrium of non-ventilated patients because of its collapsibility during inspiration. An IVC diameter of \< 21mm with collapsibility of > 50% during inspiration suggests normal right atrium pressure (between 0 and 5 mmHg), whereas a diameter of > 21mm with collapsibility of \< 50% suggests high pressure (between 10 and 20mmHg). The dynamic method of IVC evaluation, based on the variation in its diameter with respiration, enables the assessment of the potential benefit of fluid administration as a function of IVC compliance.
Ultrasonography of optic nerve sheath diameter (ONSD) in TBI patients has been shown to correlate with increased ICP and systemic reviews have supported this observation.
In this study, we will use the measurements of both lung and IVC together to guide fluid dosage in critically ill patients with TBI. We will also use ONSD as a mirror for ICP
The study investigates the effect of using bedside sonography in fluid assessment in a critically ill patient
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's planned enrollment of 72 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
fluid therapy will be guided by conventional ICU policies to maintain an adequate intravascular volume and good urine output
Procedure: Standard care (control group) · Other: Standard ICU Care
Fluid therapy will be guided by measurements of lung and IVC sonography
Procedure: US-guided fluid management (active group) · Other: Standard ICU Care
Following 24 hours from admission to the ICU, the standard care will be continued according to conventional ICU protocols The mean fluid intake will range from (2-3L per day) targeting zero or slightly negative balance (up to - 300ml). Various parameters will be used to attain this goal based on case-by-case clinical judgment.
Within 24 hours from admission to the ICU, IVC and lung sonography will be performed every other day and according to their measurements, the volume of fluid therapy will be adjusted.
All patients will receive the usual care for 24 hours according to ICU policies. The main target is to maintain an adequate intravascular volume and good urine output. The mean fluid intake will range from (2-3L per day) targeting zero or slightly negative balance (up to - 300ml). Various parameters will be used to attain this goal based on case-by-case clinical judgment. Lung sounds, heart rate, blood pressure, temperature, urine output, Lactate, haemoglobin, haematocrit, serum urea, creatinine, sodium, potassium, chloride, and bicarbonate values
Cumulative Fluid balance
The difference between patient fluid intake and patient fluid output is recorded every 24 h then the cumulative balance is recorded
Time frame: 10 days or until ICU discharge which comes first.
ONSD as mirror for intracranial pressure.
Ultrasonic examination will be performed by an experienced investigator with a 11-3 MHz linear transducer. The patients will be examined in a supine position with the head elevated at 20-30° ONSD was defined as the distance between the external borders of the hyperechoic area 3 mm posterior to the point where the optic nerve entered the globe, using an electronic caliper along the axis perpendicular to the retina. . To minimize intraobserver variability, each measurement was performed three times and the mean value was derived
Time frame: every other day for 10 days or until ICU discharge which comes first
Urine output
patient urine output per ml is collected and recorded every 6 hours and total daily urine output is recorded
Time frame: 10 days or until ICU discharge which comes first
Frequency of hypotension
hypotension is defined as systolic blood pressure less than 90 mmHg, or diastolic blood pressure less than 50 mmHg or both or more than 20 % decline in basal blood pressure for more than 5 minutes.
Time frame: every other day for 10 days or until ICU discharge which comes first
Duration of hypotension
every other day for 10 days or until ICU discharge which comes first
Time frame: 10 days or until ICU discharge which comes first
Serum creatinine
daily serum creatinine in mg /dl is ordered and recorded
Time frame: 10 days or until ICU discharge which comes first
Incidence of pulmonary edema
Diagnosis of the patient with pulmonary edema by (x ray, CT, pulse oximetry, other methods) is recorded
Time frame: 10 days or until ICU discharge which comes first
Length of mechanical ventilation
Duration of mechanical ventilation in days is record
Time frame: 10 days or until ICU discharge which comes first
Mortality at 10 days
Time frame: mortality at day 10
Plan to share: Yes — De-identified participant individual data for all primary and secondary outcomes will be made available
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
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Mansoura University