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Intracranial Hypertension clinical trials

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NCT ID: NCT03766087 Withdrawn - Clinical trials for Hypertension Intracranial

Decompressive Craniectomy for Severe Traumatic Brain Injury in Children With Refractory Intracranial Hypertension

RANDECPED
Start date: November 2019
Phase: N/A
Study type: Interventional

Severe traumatic brain injury (TBI) is the leading cause of mortality and severe disability in the pediatric population. The prognosis of these patients depends on the severity of the initial lesions but also on the effectiveness of the therapies used to prevent or at least limit secondary lesions mainly intracranial hypertension (HTIC). The medical therapeutic strategy for the control of HTIC in children with TBI is well codified: starting with hyperosmolar therapy, then hyperventilation and ultimately the use of barbiturates to deepen sedation. However, these therapies are not devoid of adverse effects (hypernatremia, cerebral hypoxemia, systemic vasodilation) and, for some, their efficacy is diminished over time. When these treatments are insufficient to lower intracranial pressure (ICP), decompressive craniectomy is proposed. Decompressive craniectomy is used in a well-coded manner in malignant ischemic stroke in adults. In TBI, to date, there are two randomized studies in adults and one in children but with a small number of patients, evaluating the benefit of decompressive craniectomy. None of them showed significantly superiority of the surgery compared to the maximal medication treatment on the functional prognosis in the medium term. However, these studies have many biases, including a significant cross-over from the conservative treatment group to the surgery arm. Nevertheless, the pediatric literature on the subject seems to yield better results on neurological prognosis in the long term. There are guidelines on the medical management of childhood TBI published by the National Institute of Health in 2012, which emphasize the need for controlled and randomized studies to define the place of decompressive craniectomy in children. That is why the investigators are proposing this national multicentre study.

NCT ID: NCT03757897 Withdrawn - Clinical trials for Cerebrospinal Fluid Pressure Increased

The Influence of Dexmedetomidine Hypnosis on Cerebrospinal Fluid (CSF) Volume, Brain Diffusion and 'Stiffness' Characteristics.

Start date: December 2021
Phase: Early Phase 1
Study type: Interventional

The primary goal is to quantify cerebrospinal fluid (CSF) volume, diffusion characteristics and mechanical properties of brain tissue at two states of arousal.

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: NCT03035838 Withdrawn - Clinical trials for Traumatic Brain Injury

Importance of Substance P in Intracranial Pressure Elevation Following Traumatic Brain Injury

NK1
Start date: November 2021
Phase: Early Phase 1
Study type: Interventional

Traumatic brain (TBI) injury is the major cause of morbidity and mortality worldwide especially in population under 40 years of age and has a significant socioeconomic impact. TBI results from the head impacting with an object or from acceleration/deceleration forces that produce vigorous movement of the brain within the skull, with the resultant mechanical forces potentially damaging neurones and blood vessels and causing irreversible, primary brain injury. Primary injury leads to activation of cellular and molecular responses which lead to disruption of the blood-brain barrier causing the brain to swell. As the intracranial space is not expandable (i.e. is fixed), this swelling leads to increase in intracranial pressure (ICP) compromising blood supply to the rest of the brain leading to secondary brain injury. As we are unable to reverse the primary injury, current protocols use supportive measures to control the ICP and ensure optimal blood supply to the brain in an attempt to minimize secondary injury. Our understanding of the factors involved in the initiation and propagation of brain swelling in TBI is growing and the role of neuroinflammatory cytokines in this process is increasingly recognized. In preclinical models of TBI, a specific inflammatory cytokine termed substance P (SP) is found to be associated with blood-brain barrier disruption and development of brain oedema in the immediate phase following injury. The aim of this study is to examine the role of SP in the genesis of cerebral oedema and elevation of ICP and thus secondary injury following human TBI. This would be achieved by blocking SP function with a SP receptor antagonist Fosaprepitant (IVEMEND®, Merck) in the first 24 hours following TBI and then continuously measuring ICP and assessing the evolvement of TBI using magnetic resonance imaging.

NCT ID: NCT02753205 Withdrawn - Clinical trials for Intracranial Hypertension

Dexmedetomidine on Optic Nerve Sheath Diameter

Start date: April 2016
Phase: N/A
Study type: Interventional

Dexmedetomidine, might attenuate the sympathetic activation and contribute to stable hemodynamics. The investigator hypothesized that continuous infusion of dexmedetomidine during laparoscopic lower abdominal surgery, might help to attenuate the increment of intracranial pressure and the investigator would observe the optic nerve sheath diameter using ultrasonography.

NCT ID: NCT02695264 Withdrawn - Clinical trials for Intracranial Hypertension

Non-invasive Intracranial Pressure (ICP) Monitoring in Pediatric Patients

Start date: August 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to prospectively evaluate the accuracy and safety of non-invasive intracranial pressure (ICP) measurements using the HeadSense-1000 (HS-1000) device compared to the current invasive external ventricular device (EVD) or parenchymal (bolt) monitoring devices in the pediatric population.

NCT ID: NCT02558309 Withdrawn - Clinical trials for Intraocular Pressure

Optic Nerve Head Quantification While Reducing Elevated Intracranial Pressure

Start date: October 2015
Phase: N/A
Study type: Observational

The goal of this study is to examine in-vivo the effect of intraocular (IOP) and intracranial pressures (ICP) on the optic nerve head (ONH). The effect of ICP on eye health has been an area of concrete research effort in recent years. The ability to acquire non-invasive and highly detailed information on both the eye and the brain using technologies such as magnetic resonance imaging (MRI) and optical coherence tomography (OCT) have paved the way to assess non-invasively the effect of ICP in-vivo. In this study, we will quantify the structural changes in the ONH in subjects with elevated ICP while they are treated to reduce the elevated pressure. This process will occur in a stepwise fashion over a period of time determined by the clinical treatment plans. We will apply controlled pressures to the eye during each step of ICP lowering while OCT images are obtained.

NCT ID: NCT02507063 Withdrawn - Clinical trials for Intracranial Hypertension

Optic Nerve Sheath Diameter and Intracranial Pressure (ICP) in Children

Start date: July 2016
Phase: N/A
Study type: Observational

The use of optic nerve sheath diameter (ONSD) measurements as a non invasive test for raised ICP has many potential benefits. This includes having assessments that can be made at the bedside instead of requiring patient transport to CT or MRI, which in itself can cause a rise in ICP. If ONSD represents an acute and sensitive measurement of elevated ICP, it may prove useful in the emergency department (ED) setting in the evaluation of shunts used for cerebrospinal fluid (CSF) diversion. The investigators hypothesize that ONSD will correlate with measured ICP and thus be a reliable tool for the bedside assessment of ICP. The investigators further hypothesize that ONSD changes will correlate with changes in ICP, making it a useful bedside tool for assessing ICP changes over time. This is a prospective, observational study using a convenience sample. Children who are 0 - 18 years old who have an invasive intracranial ICP monitoring device admitted to the hospital Pediatric Intensive Care Unit (PICU) are eligible for participation in the study. Children who are 0-18 years old who are determined to require a shunt revision following evaluation in the ED will also be included in the study. 10. After the invasive intracranial pressure monitoring device is placed, for every recruited patient, ONSD measurements will be taken and the ICP will be recorded 8 hours post placement and then repeated 3 times a day until the intracranial pressure monitoring device is removed.12. For ventriculoperitoneal (VP) shunt revision patients, the investigators will obtain a measurement just before surgery, immediately post-op, and then 12 hours, 24 hours, and 36 hours post-op. If the patient is otherwise ready for discharge prior to 36 hours, the measurement may be omitted or done early so as to not unnecessarily prolong the hospitalization

NCT ID: NCT01781585 Withdrawn - Clinical trials for End- Stage Renal Disease Patients

The Hemodynamic Effects During Sustained Low-efficiency Dialysis Versus Continuous Veno-venous Hemofiltration for Patients With Intracranial Hypertension in a Cross Over Study

NSARF
Start date: August 2011
Phase: N/A
Study type: Observational

Hemodynamic instability occurs frequently during dialysis treatment and still remains as significant cause of patient mobility and mortality. Postoperative hemodynamic optimization has been proved to reduce morbidity in high-risk patients. Intracranial pressure increased can lead to further structural and functional impairment owing to its deleterious effect on the compromised microcirculation and metabolism. This study was to compare the intra-cerebral pressure (ICP) and hemodynamic parameters between the sustained low-efficiency dialysis (SLED) and continuous veno-venous hemofiltration (CVVH) in post- brain tramatic patients.

NCT ID: NCT01215019 Withdrawn - Clinical trials for Traumatic Brain Injury

Osmotic Therapy for Treatment of Intracranial Hypertension for Traumatic Brain Injury

Start date: October 2010
Phase: N/A
Study type: Interventional

Osmotic therapy is a mainstay in the treatment of intracranial hypertension after traumatic brain injury.This study proposes to compare two hypertonic saline agents in patients with traumatic brain injury.