Efficacy of Lung and Inferior Vena Cava Sonography for Fluid Optimization
Primary Purpose
Traumatic Brain Injury
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Standard care (control group)
US-guided fluid management (active group)
Standard ICU Care
Sponsored by
About this trial
This is an interventional diagnostic trial for Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria:
- BMI less than 35 kg/m2
- Diagnosed with traumatic brain injury
- Glasgow coma score ≥ 4
Exclusion Criteria:
- Inability to get consent
- Presence of Increased intra-abdominal pressure,
- Presence of acute cor pulmonale
- Presence of severe right ventricular dysfunction.
- Pregnancy
- Patients with known pulmonary conditions that interfere with the interpretation of lung ultrasound like pneumectomy; pulmonary fibrosis; persistent pleural effusion
- Stage 5 chronic kidney disease
- indication for emergency renal replacement therapy (RRT)
Sites / Locations
- Mansoura University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard care (control group)
US-guided fluid management (active group)
Arm Description
fluid therapy will be guided by conventional ICU policies to maintain an adequate intravascular volume and good urine output
Fluid therapy will be guided by measurements of lung and IVC sonography
Outcomes
Primary Outcome Measures
Cumulative Fluid balance
The difference between patient fluid intake and patient fluid output is recorded every 24 h then the cumulative balance is recorded
Secondary Outcome Measures
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
Urine output
patient urine output per ml is collected and recorded every 6 hours and total daily urine output is recorded
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.
Duration of hypotension
every other day for 10 days or until ICU discharge which comes first
Serum creatinine
daily serum creatinine in mg /dl is ordered and recorded
Incidence of pulmonary edema
Diagnosis of the patient with pulmonary edema by (x ray, CT, pulse oximetry, other methods) is recorded
Length of mechanical ventilation
Duration of mechanical ventilation in days is record
Mortality at 10 days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05400343
Brief Title
Efficacy of Lung and Inferior Vena Cava Sonography for Fluid Optimization
Official Title
Efficacy of Lung and Inferior Vena Cava Sonography for Fluid Optimization in Critically Ill Patients With Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 15, 2022 (Anticipated)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single-blind (participant) study
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard care (control group)
Arm Type
Active Comparator
Arm Description
fluid therapy will be guided by conventional ICU policies to maintain an adequate intravascular volume and good urine output
Arm Title
US-guided fluid management (active group)
Arm Type
Experimental
Arm Description
Fluid therapy will be guided by measurements of lung and IVC sonography
Intervention Type
Procedure
Intervention Name(s)
Standard care (control group)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
US-guided fluid management (active group)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard ICU Care
Intervention Description
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
Primary Outcome Measure Information:
Title
Cumulative Fluid balance
Description
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.
Secondary Outcome Measure Information:
Title
ONSD as mirror for intracranial pressure.
Description
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
Title
Urine output
Description
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
Title
Frequency of hypotension
Description
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
Title
Duration of hypotension
Description
every other day for 10 days or until ICU discharge which comes first
Time Frame
10 days or until ICU discharge which comes first
Title
Serum creatinine
Description
daily serum creatinine in mg /dl is ordered and recorded
Time Frame
10 days or until ICU discharge which comes first
Title
Incidence of pulmonary edema
Description
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
Title
Length of mechanical ventilation
Description
Duration of mechanical ventilation in days is record
Time Frame
10 days or until ICU discharge which comes first
Title
Mortality at 10 days
Time Frame
mortality at day 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI less than 35 kg/m2
Diagnosed with traumatic brain injury
Glasgow coma score ≥ 4
Exclusion Criteria:
Inability to get consent
Presence of Increased intra-abdominal pressure,
Presence of acute cor pulmonale
Presence of severe right ventricular dysfunction.
Pregnancy
Patients with known pulmonary conditions that interfere with the interpretation of lung ultrasound like pneumectomy; pulmonary fibrosis; persistent pleural effusion
Stage 5 chronic kidney disease
indication for emergency renal replacement therapy (RRT)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa M Saied, MD
Phone
00201223495380
Email
mostafasaid1951@mans.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Medhat M Messeha, MD
Phone
00201207788199
Email
medhatmikha70@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mostafa M Saied, MD
Organizational Affiliation
Professor of Anesthesia and Surgical Intensive Care
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Medhat M Messeha, MD
Organizational Affiliation
Assistant Professor of Anesthesia and Surgical Intensive Care
Official's Role
Study Director
Facility Information:
Facility Name
Mansoura University
City
Mansourah
State/Province
DK
ZIP/Postal Code
050
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified participant individual data for all primary and secondary outcomes will be made available
IPD Sharing Time Frame
Data will be available within 6 months of study completion Data will be available for audits and quantitative meta-analyses for 10 years
IPD Sharing Access Criteria
Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement
Learn more about this trial
Efficacy of Lung and Inferior Vena Cava Sonography for Fluid Optimization
We'll reach out to this number within 24 hrs