Peri-Operative Morbidity and Quality of Life After Coronary Artery Bypass Graft (CABG)
10. april 2008 opdateret af: Weill Medical College of Cornell University
Peri-Operative Morbidity and Quality of Life After CABG
It is the long term objective of this study to preserve or improve the quality of life and to prevent deterioration in physical and mental function following myocardial revascularization among bypass surgery patients.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The objective of this study is to compare the efficacy of two strategies of intra-operative hemodynamic management in preventing peri-operative cardiac, cognitive and neurologic morbidity and mortality and postoperative deterioration in the patient's quality of life.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
248
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New York
-
New York, New York, Forenede Stater, 10065
- New York Presbyterian Hospital-Weill Cornell Medical College
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients had to be undergoing elective CABG, without concomitant valve or other cardiac surgery.
- Patients also had to be able to perform the neuropsychologic tests, and to provide informed consent.
Exclusion Criteria:
- Patients who refused to participate in the study.
- Patients who live too far away from NYC to be able to come back for follow up at six months post-operatively.
- Patients who had either valvular replacement and aortic amd mitral an aneurysm repair, or other cardiothoracic surgery.
- Patients who were unable to complete the neuropsychologic test.
- Patient who were part of another CABG study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 1
In this group (Low) the goal was to maintain MAP between 50-60 mm Hg during CPB.
|
Patients were randomized to one of two groups.
In the first group (Low) the goal was to maintain MAP between 50-60 mm Hg during CPB.
In the second group (High), the goal was to maintain MAP between 80-100 mm Hg.
In both groups, CPB flow was held constant at 1.6 L/min/M2 (cool) and 2.4 L/min/M2 (warm) and vasoactive drugs (nitroglycerin or phenylephrine) were used to maintain MAP in the desired range.
MAP was controlled in this fashion from the onset of CPB through separation from CPB began.
Andre navne:
|
|
Eksperimentel: 2
In this group (High), the goal was to maintain MAP between 80-100 mm Hg during CPB.
|
Patients were randomized to one of two groups.
In the first group (Low) the goal was to maintain MAP between 50-60 mm Hg during CPB.
In the second group (High), the goal was to maintain MAP between 80-100 mm Hg.
In both groups, CPB flow was held constant at 1.6 L/min/M2 (cool) and 2.4 L/min/M2 (warm) and vasoactive drugs (nitroglycerin or phenylephrine) were used to maintain MAP in the desired range.
MAP was controlled in this fashion from the onset of CPB through separation from CPB began.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Cardiac morbidity
Tidsramme: 6-months after surgery
|
6-months after surgery
|
|
Neurologic morbidity
Tidsramme: 6-months after surgery
|
6-months after surgery
|
|
Mortality
Tidsramme: 6-months after surgery
|
6-months after surgery
|
|
Functional status
Tidsramme: 6-months after surgery
|
6-months after surgery
|
|
Neurocognitive function
Tidsramme: 6-months after surgery
|
6-months after surgery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 1991
Studieafslutning (Faktiske)
1. september 1994
Datoer for studieregistrering
Først indsendt
3. november 2005
Først indsendt, der opfyldte QC-kriterier
3. november 2005
Først opslået (Skøn)
4. november 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. april 2008
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. april 2008
Sidst verificeret
1. april 2008
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 0001004169 (Formerly 0100-006)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .