Who is sponsoring NCT01455376?

NCT01455376 is sponsored by Universitas Padjadjaran.

What drugs are being tested in NCT01455376?

Interventions in NCT01455376: hyperosmolar sodium lactate.

What condition does NCT01455376 study?

NCT01455376 studies Traumatic Brain Injury.

Is NCT01455376 still recruiting?

NCT01455376 is currently completed. Last updated 20 October 2011.

Last reviewed 2011-10-20 · How we verify

NCT01455376

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effect of Exogenous Lactate Infusion on Neurocognitive Function of Patients With Mild Traumatic Brain Injury

Completed NA Last updated 20 October 2011

What this trial tests

NA trial testing hyperosmolar sodium lactate in Traumatic Brain Injury in 60 participants. Completed in 1 June 2010.

Timeline

1 March 2010

Primary endpoint
1 June 2010

1 June 2010

Quick facts

Lead sponsor	Universitas Padjadjaran
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	1 March 2010
Primary completion	1 June 2010
Estimated completion	1 June 2010
Sites	1 location across Indonesia

Drugs / interventions tested

hyperosmolar sodium lactate — full drug profile →

Conditions studied

Traumatic Brain Injury — all drugs for Traumatic Brain Injury →

Sponsor

Universitas Padjadjaran — full company profile →

Who can join

Adults 14 to 60, any sex, with Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Changes in neurocognitive function
Time frame: 24 hours, 30 days, and 90 days post surgery
The investigators evaluate the changes in neurocognitive function at several time points (24 hours, 30 days, and 90 days post surgery) using Mini Mental State Examination (MMSE) score in both groups. Osmolality and sodium level are also recorded in order to confirm that hyperosmolar sodium lactate is safe for traumatic brain injury patients

Sponsor's own description

Mild traumatic brain injury (TBI) is the most common type of brain injury. Post-mild TBI disability could stem from cognitive, physical, psychological and social dysfunction which resulted in significant disability and unemployment. Long-term behavioral impairments which affected the individual's occupation, lifestyle, and family frequently occurred in individuals with mild to moderate brain injuries who physically fully recovered. In-vitro and in-vivo studies showed a better recovery of cognitive function after administration of exogenous lactate in traumatic brain injury. Therefore, this study is aimed to evaluate the effect of exogenous lactate infusion contained in hyperosmolar sodium lactate solution on cognitive function assessed by Mini Mental State Examination(MMSE)scale.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Traumatic Brain Injury

Currently open trials in the same condition.

NCT07176936 — Improving Speech in Noise Using Noninvasive Stimulation · NA · recruiting
NCT07473505 — Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospect · recruiting
NCT07455136 — A Study to Develop a Blood-based Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adults and for Mon · recruiting
NCT07404761 — Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments · NA · recruiting
NCT07230002 — Effects of Moderate/Severe Traumatic Brain Injury in the Subacute or Chronic Phase on Locomotor Strategies Involved in N · NA · recruiting

Other Universitas Padjadjaran trials

Trials by the same sponsor.

NCT07506486 — Effect of Immersive Virtual Reality Cognitive Rehabilitation on Subacute Stroke Patients (A Pilot Study) · NA · not yet recruiting
NCT07494357 — Effects of Dual Task-Oriented Circuit Training on Walking Recovery in Sub-acute Stroke · NA · not yet recruiting
NCT07451899 — TB Type and Spirometry Result vs. Functional Capacity Based on 6MWT in People With Post-TB Lung Disease · not yet recruiting
NCT07467954 — Comparative Effectiveness of Long-Pulsed 1064-nm Nd:YAG and Fractional CO₂ Laser in Skin Rejuvenation · NA · recruiting
NCT07344688 — The Effect of White Tea in Healthy Human Subjects · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01455376 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Universitas Padjadjaran
Last refreshed: 20 October 2011

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01455376.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing