Efficacy of Lung and Inferior Vena Cava Sonography for Fluid Optimization

NCT05400343 | Unknown DMC

• 1 other identifier: MFM-IRB, MD ∕ 22.01.591
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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).

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Cumulative Fluid balance

  The difference between patient fluid intake and patient fluid output is recorded every 24 h then the cumulative balance is recorded

  10 days or until ICU discharge which comes first.

Secondary Outcomes (8)

• ONSD as mirror for intracranial pressure.

  every other day for 10 days or until ICU discharge which comes first

• Urine output

  10 days or until ICU discharge which comes first

• Frequency of hypotension

  every other day for 10 days or until ICU discharge which comes first

• Duration of hypotension

  10 days or until ICU discharge which comes first

• Serum creatinine

  10 days or until ICU discharge which comes first

Study Arms (2)

Standard care (control group)

ACTIVE COMPARATOR

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

US-guided fluid management (active group)

EXPERIMENTAL

Fluid therapy will be guided by measurements of lung and IVC sonography

Procedure: US-guided fluid management (active group); Other: Standard ICU Care

Interventions

Standard care (control group) PROCEDURE

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.

Standard care (control group)

US-guided fluid management (active group) PROCEDURE

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.

US-guided fluid management (active group)

Standard ICU Care OTHER

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

Standard care (control group); US-guided fluid management (active group)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI less than 35 kg/m2
• Diagnosed with traumatic brain injury
• Glasgow coma score ≥ 4

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Standard of Care; Control Groups

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Mostafa M Saied, MD

  Professor of Anesthesia and Surgical Intensive Care

  STUDY CHAIR

• Medhat M Messeha, MD

  Assistant Professor of Anesthesia and Surgical Intensive Care

  STUDY DIRECTOR

Central Study Contacts

Mostafa M Saied, MD

CONTACT

00201223495380; mostafasaid1951@mans.edu.eg

Medhat M Messeha, MD

CONTACT

00201207788199; medhatmikha70@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind (participant) study
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 1, 2022
• Study Start: June 15, 2022
• Primary Completion: April 1, 2023
• Study Completion: September 1, 2023
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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
• Access Criteria: Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement

Locations

EG (1)