Effects of Oxygen Treatment on Mechanisms Involved in Ischemia-reperfusion Injury: A Pilot Study in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Myocardial InfarctionInflammationAcute Coronary Syndrome (ACS)Reperfusion Injury
Interventions
BIOLOGICAL

Salmonella typhi vaccine (Typhim Vi®)

A peripheral venous catheter will be inserted. This catheter will be used to collect blood sample during the study day. In addition, peripheral oxygen saturation will be measured by pulse oximetry. After baseline venous blood samples have been collected, all study participants will receive 0.5 mL of the Salmonella typhi vaccine as an intramuscular injection (Typhim Vi®, Sanofi Pasteur MSD, injection solution 25 microgram/0.5 mL) Venous blood samples will be collected at 3, 6 and 8 hours after baseline. After the 8-hour blood sampling, the peripheral venous catheter will be removed and the study day ended.

DRUG

Oxygen (Oxymask®)

"As in arm 1. Half an hour after vaccination is administered, oxygen treatment will be initiated at 6 L/min via Oxymask® and continued for 6 hours. During oxygen treatment peripheral oxygen saturation will be measured by pulsoximetry.~Venous blood samples will be collected at 3, 6 and 8 hours after baseline. After the 8-hour blood sampling, the peripheral venous catheter will be removed and the study day ended."

DRUG

Atorvastatin

As in arm 1. Half an hour after vaccination is administered, oxygen treatment will be initiated at 6 L/min via Oxymask® and continued for 6 hours. During oxygen treatment peripheral oxygen saturation will be measured by pulsoximetry. A single dose of Atorvastatin 80 mg will be given immediately prior to start of oxygen. Venous blood samples will be collected at 3, 6 and 8 hours after baseline. After the 8-hour blood sampling, the peripheral venous catheter will be removed and the study day ended.

Trial Locations (1)

58191

Linköping University Hospital, Linköping

All Listed Sponsors
collaborator

University Hospital, Linkoeping

OTHER

lead

Karolinska Institutet

OTHER

NCT02286544 - Effects of Oxygen Treatment on Mechanisms Involved in Ischemia-reperfusion Injury: A Pilot Study in Healthy Volunteers | Biotech Hunter | Biotech Hunter