Acute Lung Injury After Cardiac Surgery: Pathogenesis (ALI)
16 juni 2015 uppdaterad av: Bodil Steen Rasmussen, Aalborg University Hospital
The purpose of the present study is to visualize the inflammatory response and coagulation disorders during cardiac surgery in order to identify possible predictors for acute lung injury postoperatively.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Acute lung injury after cardiac surgery is a common complication. The pathophysiology is complex and still not fully elucidate. No specific biomarkers are identified and the diagnosis is solely based on impaired oxygenation.
The purpose of the present study is to identify biomarkers of inflammation and coagulation in blood withdrawn simultaneous from the pulmonary artery and the left atrium during surgery and up to 20 hours after weaning from cardiopulmonary bypass.
Studietyp
Observationell
Inskrivning (Faktisk)
50
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 90 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
Patients scheduled for elective coronary artery bypass grafting (CABG)
Beskrivning
Inclusion Criteria:
- Elective surgery
- CABG
- In treatment with statins
Exclusion Criteria:
- Acute surgery
- Valve replacement
- In treatment with immunodepressive drugs
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Acute lung injury measured as the fraction of partial pressure of oxygen divided by the fraction of inspired oxygen
Tidsram: Evaluated 72 hours after weaning from cardiopulmonary bypass (CPB)
|
Arterial blood gas analysis
|
Evaluated 72 hours after weaning from cardiopulmonary bypass (CPB)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Interleukin-1beta
Tidsram: The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB
|
Measured in blood samples from radial artery, pulmonary artery and left atrium
|
The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB
|
|
Interleukin-2
Tidsram: The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB
|
Measured in blood samples from radial artery, pulmonary artery and left atrium
|
The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB
|
|
Interleukin-4
Tidsram: The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB
|
Measured in blood samples from radial artery, pulmonary artery and left atrium
|
The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB
|
|
Interleukin-6
Tidsram: The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB
|
Measured in blood samples from radial artery, pulmonary artery and left atrium
|
The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB
|
|
Interleukin-8
Tidsram: The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB
|
Measured in blood samples from radial artery, pulmonary artery and left atrium
|
The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB
|
|
Interleukin-10
Tidsram: The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB
|
Measured in blood samples from radial artery, pulmonary artery and left atrium
|
The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB
|
|
Tumor necroting factor-alpha
Tidsram: The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB
|
Measured in blood samples from radial artery, pulmonary artery and left atrium
|
The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB
|
|
Interferon-gamma
Tidsram: The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB
|
Measured in blood samples from radial artery, pulmonary artery and left atrium
|
The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB
|
|
Granulocyte-macrophage colony-stimulating factor
Tidsram: The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB
|
Measured in blood samples from radial artery, pulmonary artery and left atrium
|
The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB
|
|
Thrombin-antithrombin complexes
Tidsram: The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB
|
Measured in blood samples from pulmonary artery and left atrium
|
The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB
|
|
Plasmin-antiplasmin complexes
Tidsram: The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB
|
Measured in blood samples from pulmonary artery and left atrium
|
The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB
|
|
D-dimer
Tidsram: The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB
|
Measured in blood samples from pulmonary artery and left atrium
|
The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB
|
|
Thrombin Fragment 1.2
Tidsram: The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB
|
Measured in blood samples from pulmonary artery and left atrium
|
The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB
|
|
Metabolomics
Tidsram: The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB
|
Metabolomics using the NMR-technique in blood samples from radial artery, pulmonary artery and left atrium
|
The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Bodil S Rasmussen, MD, PhD, Aalborg University Hospital
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2008
Primärt slutförande (Faktisk)
1 mars 2009
Avslutad studie (Faktisk)
1 mars 2009
Studieregistreringsdatum
Först inskickad
21 maj 2015
Först inskickad som uppfyllde QC-kriterierna
16 juni 2015
Första postat (Uppskatta)
19 juni 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
19 juni 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 juni 2015
Senast verifierad
1 juni 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- N-20080016
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .