Effects of Repetitive Hyperbaric Oxygen Therapy in Patients With Acute Ischaemic Stroke

Acute Stroke Clinical Trial

Official title:

Effects of Repetitive Hyperbaric Oxygen Therapy in Patients With Acute Ischaemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03431402
• Other study ID #: KasrELAiniH critical care dep.
• Status: Recruiting
• Phase: N/A
• First received: February 1, 2018
• Last updated: March 13, 2018
• Start date: March 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: March 2018
• Source: Kasr El Aini Hospital
• Contact: Ibrahim Shehata, MSC
• Phone: 001011946001
• Email: shehata772[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background and Rationale:

Cerebrovascular disease is always ranked at the top causes of death and most of hospitalized acute stroke patients have ischemic stroke [1].

Although the mortality rate of acute ischemic stroke is less than that of hemorrhagic stroke [1], it still results in patient disabilities and complications that often lead to significant costs to individuals, families, and society.

Traditional treatment for acute ischemic stroke includes thrombolytic therapy by injecting tissue plasminogen activator (t-PA) within three hours after onset of symptoms [2], antiplatelets and/or anticoagulant agents administered within the first 48 hours. Clinically, the narrow time window of thrombolytic therapy and coexisting contraindications limit the use of t-PA [2]. Thus, searching for an effective supplemental treatment for acute ischemic stroke is imperative.

Hyperbaric oxygen therapy (HBOT) is valuable in treating acute carbon monoxide poisoning [3,4], air or gas embolism [5], facilitating wound healing [6] and has been used as an adjuvant treatment for many neurological disorders that need further study as concussion [7] , stroke [8,9], cerebral palsy [ 10],traumatic brain injury [ 11], cerebral air embolism [12], Autism [13] and multiple sclerosis [14].

Indications of hyperbaric oxygen therapy recommended by undersea and hyperbaric medical society (UHMS) [15] are 1.air or gas embolism [5], 2.carbon monoxide poisoning [3,4], 3.clostridial myositis and myonecrosis [16], 4.crush injury, compartment syndrome and other acute traumatic ischemias [17], 5.decompression sickness [18], 6.arterial insufficiencies [19], 7.severe anemia [20], 8.intracranial abscess [21], 9.necrotizing soft tissue infections [22],10. refractory osteomyelitis [23], 11.delayed radiation injury [24], 12.compromised grafts and flaps [25], 13.acute thermal burn injury [26] and 14.idiopathic sudden sensorineural hearing loss [27].

Known mechanisms of HBOT-induced neuroprotection include enhancing neuronal viability via increased tissue oxygen delivery to the area of diminished blood flow, reducing brain edema, and improving metabolism after ischemia [28,29]. Furthermore, a recent study performed on a rat suggested that upregulation of the expression of glial derived neurotrophic factor (GDNF) and nerve growth factor (NGF) might underlie the effect of HBOT [30].

The effectiveness of use of Hyperbaric oxygen therapy in human ischemic stroke is still controversial that need further evaluation.

Description:

Study Methods:

Study Population A 60 adult (aged >18 years) patients were included with a diagnosis of acute thromboembolic ischemic stroke within 48 hours after onset, according to clinical picture and imaging findings by brain computed tomography (CT) without evidence of hemorrhage, upon admission to the hospital and no patient received thrombolytic therapy.

Inclusion criteria:

Group one, HBOT group (n = 30): thirty adult patients with acute ischemic stroke will receive conventional medical treatment ( as antiplatelet but not thrombolytic therapy) with 10 sessions of adjunctive hyperbaric oxygen therapy (HBOT) within 3-5 days after the onset of stroke .

Compared with Group two, control group(n = 30): thirty adult patients with acute ischemic stroke will receive conventional medical treatment alone.

The baseline clinical characteristics were similar in both groups.

Exclusion criteria:

• Patient with cerebral hemorrhage

• Patient received thrombolytic therapy

• Emphysema with carbon dioxide retention

• Pneumothorax

• Seizure disorder

• Uncontrolled high fever

Demographic Characteristics:

Adults more than 18 years, Any gender. All patients upon admission to the hospital will provide:

Complete history taking:Age, Gender, Smoking, Alcohol consumption, Past history: diabetes mellitus , hypertension , Chronic obstructive pulmonary disease, Epilepsy or cardiovascular disease.

Neurological assessment use NIHSS score Blood tests:Complete blood count , Coagulation profile, Fasting blood sugar., Renal function test (Urea and creatinine).

CT brain

Chest x-ray :

Electrocardiogram (ECG):

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria:

• Adult patients with acute ischemic stroke

• Glasgow coma scale more than 10

Exclusion criteria:

• Patient with cerebral hemorrhage

• Patient received thrombolytic therapy

• Emphysema with carbon dioxide (CO2) retention

• Pneumothorax

• Seizure disorder

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Drug:
• Hyperbaric oxygen
- HBOT group will receive 10 sessions of HBOT at 2.0 Atmosphere absolute (ATA) for one hour in a hyperbaric chamber pressured with compressed air, whereby patients will breath 100% oxygen to 2 ATA started within 3-5days after the onset of stoke plus conventional therapy as antiplatelets therapy, correction of hypovolaemia , hypoxia and adequate nutrition

Locations

Country	Name	City	State
Egypt	Ibrahim Shehata Hussin	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in national institute of health stroke score before and after treatment with hyperbaric oxygen therapy	The national institute of health stroke score (NIHSS) is a 15 item neurologic examination that provides a quantitative measure of stroke-related neurologic deficit. (Maximum score of 42) "Mild" disease was defined as score of 0-14, "moderate" as 15-28, and "severe" as 29-42.; As pretreatment evaluation, all patients will be evaluated by national institute of health stroke score within 48 hours after admission.; As posttreatment evaluation, patients in the hyperbaric oxygen therapy group were evaluated by national institute of health stroke score after 10 sessions of hyperbaric oxygen therapy.; The control group was evaluated with national institute of health stroke score 10 days after stroke onset.; One month after treatment, all patients were evaluated again using the national institute of health stroke score.	2 years
Secondary	Hospital mortality		2 years
Secondary	Hospital length of stay		2 years