- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05101278
ROS in TBI Patients in Relation to Level of Oxygenation. (ROS-TBI)
Formation of Reactive Oxygen Species in Patients With Severe Traumatic Brain Injury in Normal vs Increased Oxygenation.
This project an observational study performed on patients with severe Traumatic Brain Injury (TBI) treated at Neurosurgical ICU (NICU) at Karolinska University Hospital. The purpose of this study is to evaluate the effects of various oxygenation levels on production rate of Reactive Oxygen Species (ROS) in patients with severe traumatic brain injury (TBI). The patients will be included in the study after the placement of intracranial monitoring device consisting of intracranial pressure gage (Codman), microdialysis (MD), and Licox oxygen electrode for measurement of partial pressure of oxygen in brain tissue (pBtO2). Intracranial monitoring is inserted on clinical indications and is used for early detection of deleterious processes in brain tissue such as hypoxia or hypoperfusion and for purpose of guiding of given therapies such as cerebral perfusion pressure (CPP), oxygenation, dosage of vasoactive drugs etc. Despite the technical possibilities to monitor all these physiological parameters, there are no clear guidelines how to interpret the MD and pBtO2 data and implement it in clinical decision making. One of the controversies deals with optimization of oxygen levels: some authors point out the importance of adequate brain tissue oxygenation, whereas other researchers are worried about the possible negative effects of excessive oxygen levels such as increased production of ROS or facilitating pulmonary atelectasis, contributing to adverse outcome.
The purpose of this study is to investigate the effect of various oxygenation levels on ROS production in TBI patients.
This pilot study is designed to measure short-lived ROS in blood and microdialysis fluid samples of TBI patients during alternating periods of normal vs temporarily increased oxygenation levels under normobaric conditions (normal atmospheric pressure).
Studieoversikt
Status
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
-
-
Stockholm, Sverige, 17176
- Karolinska University Hospital
-
Ta kontakt med:
- Michael Nekludov, MD PhD
- E-post: michael.nekludov@regionstockholm.se
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Severe isolated TBI (GCS<8, AIS =<3), CT-verified TBI (tSDH,tEDH, tSAH, contusion bleedings) caused by blunt or penetrating trauma.
- Established intracranial monitoring (ICP, MD, LiCox pBtO2) at NICU.
- Age >= 18
- Time from trauma from 0 to 4 days.
- Informed consent from Close relative.
- Systemic hyperoxygenation can be used in patients with pBtO2 <20 mmHg, based on clinical decision.
Exclusion Criteria:
- Major extracranial injury, AIS >3
- Brain dead or expected survival <24 hours
- Pregnancy
- Respiratory insufficiency FiO2> 40%
6. No consent from relative.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
ROS concentrations in blood
Tidsramme: 7 days
|
ROS concentrations in patient´s blood will be measured repeatedly at normal systemic oxygenation and at increased oxygenation if necessary.
|
7 days
|
Markers of oxidative stress
Tidsramme: 7 days
|
Indirect markers of oxydative stress, as MDA (Malondialdehyde) and Isoprostane F2, in relation to level of systemic oxygenation.
|
7 days
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- K2020-1148
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .