Clinical trial NCT03777683: Evaluation the Effects of French Maritime Pine Bark Extract on the Clinical Status in Traumatic Brain Injury Patients
Official title: Evaluation the Effects of French Maritime Pine Bark Extract Supplementation on the Inflammatory Biomarkers, Nutritional and Clinical Status in Traumatic Brain Injury Patients, in Intensive Care Unit; A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Traumatic Brain Injury
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Traumatic brain injury (TBI) is one of the major health and socioeconomic problems in the world. Immune-enhancing enteral formula has been proven to significantly reduce infection rate in TBI patient. One of the ingredients that can be used in immunonutrition formulas to reduce inflammation and oxidative stress is French maritime pine bark extract.

Objective: The main objective of present study is surveying the effect of French maritime pine bark extract on the clinical, nutritional and inflammatory status of TBI patients as the first human study in the world.

Method: this is double-blind, randomized controlled trial. Block randomization are used. Intervention group will receive French maritime pine bark extract supplement (OLIGOPIN) 150 mg for 10 days. Control group will receive placebo for the same duration. Inflammatory status (IL-6, IL- 1β, C-reactive protein) and oxidative stress status (Malondialdehyde, total antioxidant capacity), at the base line, at the 5th day and at the end of the study (10th day) are measured. APACHE ІІ (acute physiologic and chronic health evaluation II) for assessment of clinical status of patients and Nutric questionnaires for assessment of nutritional status filled out at the base line, 5th day and the end of study. SOFA (sequential organ failure assessment) questionnaire for assessment of organ failure filled out every other day. The mortality rate will be asked by phone within 28 days of the start of the intervention. Weight, body mass index and body composition at baseline, 5th day and 10th day of intervention are measured. All analyses will be conducted by initially assigned study arm in an intention-to-treat analysis. The data will be expressed as mean ± SD.

Detailed description: Randomization:

investigators randomly assign eligible patients on enrolment (1:1) to either the control group or the intervention group. Randomization is stratified by site and a randomization list of unique patient identifiers is generated by the study statistician using a computer-generated random block size. The classification is based on age (18 to 40 and 40 to 65 years old), gender (male / female) and APACHEII score (0 to 35 and 35 to 71) using quadruple blocks.

Eligibility criteria: Inclusion Criteria:

* Admission in ICU due to TBI2
* 18 year ≤ age ≤ 65 year
* GCS score ˃ 8
* Stable hemodynamic and metabolic status in the first 24 to 48 hours
* Having enteral nutritional support
* Fill out the informed consent form by the patient or first-degree relatives of the patient

Exclusion Criteria:

* Pregnancy and lactation
* Morbid obesity: BMI ≥ 40
* Failure to start enteral nutrition in the first 24-48 hours
* Suffering from autoimmune disorders and HIV/Aids
* Suffering or having History of cancer and any liver failure
* Receiving positive inotropic medications including Dopamine, Dobutamine and Epinephrine
* Severe and active bleeding
* Suffering from Sepsis
* Having history of known food allergies

Primary outcomes:
measure: change of IL-6
timeFrame: 5 and 10 days
measure: change of IL-1β
timeFrame: 5 and 10 days
measure: change of CRP
timeFrame: 5 and 10 days
measure: change of Malondialdehyde
timeFrame: 5 and 10 days
measure: change of total anti- oxidant capacity
timeFrame: 5 and 10 days
measure: change of weight
timeFrame: 5 and 10 days
measure: change of body fat percentage
timeFrame: 5 and 10 days
measure: change of Body mass index
timeFrame: 5 and 10 days
measure: change of acute physiologic and chronic health evaluation II score
timeFrame: 5 and 10 days
measure: change of sequential organ failure assessment score
timeFrame: 1, 3, 5, 7, 9, 10 days
measure: change of Nutric score
timeFrame: 5 and 10 days
Secondary outcomes:
measure: 28-day mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Mahsa Malekahmadi
Study officials:
References:
citation: Malekahmadi M, Moradi Moghaddam O, Islam SMS, Tanha K, Nematy M, Pahlavani N, Firouzi S, Zali MR, Norouzy A. Evaluation of the effects of pycnogenol (French maritime pine bark extract) supplementation on inflammatory biomarkers and nutritional and clinical status in traumatic brain injury patients in an intensive care unit: A randomized clinical trial protocol. Trials. 2020 Feb 11;21(1):162. doi: 10.1186/s13063-019-4008-x.