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Brain Edema clinical trials

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NCT ID: NCT03573999 Completed - Clinical trials for Metabolic Disturbance

Effect of Mannitol 20% Versus Hypertonic Saline 7.5% in Brain Metabolism and Oxygenation

Start date: June 29, 2018
Phase: Phase 4
Study type: Interventional

Usage of osmotic agents is a standard practice in neuroanesthesia since cerebral edema is a very common situation for patients with pathology in the brain. Cerebral edema is defined as the accumulation of fluid in the intracellular or extracellular compartments of the brain. Among other situations that have nothing to do with the brain, a supratentorial pathology such as a tumor, traumatic injury or an aneurysm, will lead to disruption of blood-brain barrier, and energy crisis of the cells that will cause mainly vasogenic and cytotoxic cerebral edema. The most common monitoring method for "measuring" cerebral edema is ICP (intracranial pressure) in which normal values are (with differences in the bibliography) 10-15 mmHg. The osmotic agents used most in neuroanesthesia are mannitol 20% and hypertonic NaCl 7.5% or 3%. Their brain relaxation effectiveness is supposed to be quite the same between the two different agents. Their main difference is that mannitol induces diuresis. Also, electrolyte disorders are another possibility after mannitol infusion. On the other hand, NaCl 7.5% causes vasodilation, does not induce diuresis and hemodynamically, even though it reduces SBP, it raises CO because of its excessive vasodilation. But both reduce cerebral edema due to the change of osmotic pressure in the vessels, that leads to extracting water from brain cells. A supratentorial craniotomy is de facto worsening the oxygenation and metabolism condition of the surgical site, adding to the problem the intracranial pathology causes in the first place. So if oxygen provided is low and the metabolic rate is high, the rate of anaerobic metabolism will raise. Measuring the oxygen in the jugular bulb is the most reliable monitoring method of cerebral oxygenation and metabolism. It becomes evident that optimization of cerebral oxygenation during a craniotomy will possibly affect the outcome of a patient, by improving it. So, if any superiority of one osmotic agent over the other could be demonstrated this will be very helpful in the decision making in routine clinical practice.

NCT ID: NCT03409237 Withdrawn - Clinical trials for Intracranial Hypertension

Coagulation Activation by Hyperosmolar Agents in Intracranial Hypertension

Start date: December 3, 2020
Phase:
Study type: Observational

Osmotherapy consists in the therapeutic use of osmotically active substances with the aim of reducing the volume and therefore the intracranial pressure. It therefore represents an essential component in the clinical management of cerebral edema and intracranial hypertension, whether they are a consequence of head trauma, ischemic or hemorrhagic stroke, and neoplasm or neurosurgical procedures. The current study aims at evaluating in vivo the effects on haemostasis parameters of hypertonic saline solutions at different concentration, as compared to mannitol, in patients with neuroradiological signs (CT / MRI) of cerebral edema / non-traumatic intracranial hypertension.

NCT ID: NCT03341676 Completed - Clinical trials for High Altitude Cerebral Edema

Spectroscopic and Diffusion Weighted Analysis of the Effects of Dexamethasone on High Altitude Cerebral Oedema (HACE)

D4H
Start date: January 14, 2019
Phase: Phase 1
Study type: Interventional

When the brain detects a drop in oxygen levels in the blood (hypoxia) there is a compensatory increase in blood flow. Acute mountain sickness (AMS) is a cluster of symptoms which commonly occur in those ascending to high altitude and experiencing hypoxia due to increased blood flow and then swelling in the brain. Symptoms include headache, nausea, insomnia and fatigue. The exact mechanisms by which AMS develops remains poorly understood. Dexamethasone has been shown to reduce the risk of developing significant brain swelling in other settings. Therefore we hypothesise that administering low dose Dexamethasone could protect against hypoxia induced cerebral and spinal oedema.

NCT ID: NCT03330704 Withdrawn - Cerebral Edema Clinical Trials

Small-Volume, Patient-Specific, Balanced Hypertonic Fluid Protocol Validation

Start date: November 28, 2017
Phase: Early Phase 1
Study type: Interventional

Many patients with traumatic brain injuries (including strokes, blood clots, or other brain injuries) are given concentrated salt water solutions (hypertonic saline) in order to treat brain swelling (cerebral edema). Current therapies consist of a mixture of sodium and chloride, which can lead to high levels of serum chloride and increased total body water. High levels of chloride can cause acidosis, which can cause the body to function sub-optimally. Therefore, the investigators are proposing to use two concentrated solutions in these patients at the same time that will allow for a lower total volume of solution administration and reduce the rise in chloride to prevent acidosis. The main outcome will therefore be the patients sodium level, chloride level and serum pH.

NCT ID: NCT03323580 Completed - Brain Tumor Clinical Trials

Effects of Intraoperative GDFT on the Postoperative Brain Edema

Start date: November 26, 2018
Phase: N/A
Study type: Interventional

Whether a fluid protocol aiming for protecting vital organ perfusion or fluid restriction is favorable to post-craniotomy outcomes such as brain edema remains uncertain. To our knowledge, there has been no extensive and quantitative analysis of brain edema following SVV-based GDFT in neurosurgical patients with malignant supratentorial glioma. So the study aims to observe the effect of the stroke volume variation-based GDFT on the postoperative brain edema and decrease the incidence of postoperative complications in neurosurgical patients with malignant supratentorial gliomas.

NCT ID: NCT03300648 Completed - Malaria, Cerebral Clinical Trials

Treating Brain Swelling in Pediatric Cerebral Malaria

TBS
Start date: January 8, 2018
Phase: Phase 3
Study type: Interventional

This study evaluates the effectiveness of two interventions in Malawian children with cerebral malaria at high risk of death. One-third of the participants will receive treatment as usual, one-third will receive treatment as usual and be placed on a mechanical ventilator, and one-third will receive treatment as usual plus intravenous hypertonic saline.

NCT ID: NCT03276494 Completed - Stroke Clinical Trials

Safety & Tolerability of Hypertonic Saline Administration Via Intraosseous Access

Start date: April 21, 2017
Phase: Phase 2
Study type: Interventional

Hypertonic saline is used to treat elevated intracranial pressure. Intraosseous vascular access has been used to administer fluids and medications. This study combines these to administer 3% hypertonic saline via IO.

NCT ID: NCT03243539 Active, not recruiting - Stroke Clinical Trials

Implementation of Neuro Lung Protective Ventilation

NEUROVENT
Start date: August 31, 2017
Phase: N/A
Study type: Interventional

Patients who experience lung injury are often placed on a ventilator to help them heal; however, if the ventilator volume settings are too high, it can cause additional lung injury. It is proven that using lower ventilator volume settings improves outcomes. In patients with acute brain injury, it is proven that maintaining a normal partial pressure of carbon dioxide in the arterial blood improves outcomes. Mechanical ventilator settings with higher volumes and higher breathing rates are sometimes required to maintain a normal partial pressure of carbon dioxide. These 2 goals of mechanical ventilation, using lower volumes to prevent additional lung injury but maintaining a normal partial pressure of carbon dioxide, are both important for patients with acute brain injury. The investigators have designed a computerized ventilator protocol in iCentra that matches the current standard of care for mechanical ventilation of patients with acute brain injury by targeting a normal partial pressure of carbon dioxide with the lowest ventilator volume required. This is a quality improvement study with the purpose of observing and measuring the effects of implementation of a standard of care mechanical ventilation protocol for patients with acute brain injury in the iCentra electronic medical record system at Intermountain Medical Center. We hypothesize that implementation of a standardized neuro lung protective ventilation protocol will be feasible, will achieve a target normal partial pressure of carbon dioxide, will decrease tidal volumes toward the target 6 mL/kg predicted body weight, and will improve outcomes.

NCT ID: NCT03000283 Completed - Stroke Clinical Trials

Conivaptan for the Reduction of Cerebral Edema in Intracerebral Hemorrhage- A Safety and Tolerability Study

Start date: March 22, 2017
Phase: Phase 1
Study type: Interventional

The goal of this study is to preliminarily determine/estimate feasibility and whether frequent and early conivaptan use, at a dose currently determined to be safe (i.e., 40mg/day), is safe and well-tolerated in patients with cerebral edema from intracerebral hemorrhage (ICH) and pressure (ICP). A further goal is to preliminarily estimate whether conivaptan at this same dose can reduce cerebral edema (CE) in these same patients. This study is also an essential first step in understanding the role of conivaptan in CE management. Hypothesis: The frequent and early use of conivaptan at 40mg/day will be safe and well-tolerated, and also reduce cerebral edema, in patients with intracerebral hemorrhage and pressure.

NCT ID: NCT02937441 Completed - Cerebral Edema Clinical Trials

Evaluation of the Cerebral Edema in Children Having Diabetic Ketoacidosis

Start date: August 2016
Phase:
Study type: Observational

The purpose of this study is to determine cerebral edema with evaluation of measurement of diameter of optic nerve sheath.