- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00725972
Pre-emptive Hemodynamic Optimization of High Risk Patients Undergoing Elective Major Surgical Procedures
Pre-emptive Hemodynamic Optimization of High Risk Patients Undergoing Elective Major Surgical Procedures.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Forenede Stater, 15213
- UPMC-Presbyterian Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adult, Male or female.
- Patients undergoing elective major surgery.
- Patients with normal renal function.
- All patients will sign informed consent.
Exclusion Criteria:
- Major organ failure.
- Low cardiac output conditions.
- Pulmonary hypertension.
- Severe pulmonary disease.
- Patient refusal to participate in the study.
- Pregnancy.
- Emergency Surgery.
- Lithium allergy or patient on lithium.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Augmented Oxygen Delivery Group
Hemodynamic management to a goal of O2 delivery of 600 ml/m2/min utilizing cardiac stroke volume variation with positive pressure ventilation to optimize fluid management. Intervention: Augment O2 Delivery by hemodynamic protocol. (7/30/17: deleted original text which apparently was pasted from an entirely unrelated study having to do with age of transfused blood, presumably by the creator of this record, Cynthia Hatfield, in 2010. SLW) |
Hemodynamic management to a goal of O2 delivery of 600 ml/m2/min utilizing cardiac stroke volume variation with positive pressure ventilation to optimize fluid management.
|
Sham-komparator: Control
Patients having the same types of surgery but receiving usual anesthetic care.
Intervention: High Risk Surgery.
(7/30/17: deleted original text which apparently was pasted from an entirely unrelated study having to do with age of transfused blood, presumably by the creator of this record, Cynthia Hatfield, in 2010.
SLW)
|
Patients with same characteristics as Experimental Group having same types of Surgery but no change to usual anesthetic care
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Duration of mechanical ventilation. Duration of ICU and hospital stay. Infection Renal function. Bowel movement. Oral intake. 3-month period Quality of life.
Tidsramme: 3 months
|
3 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
As in the primary
Tidsramme: 3 months
|
3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Steven L Whitehurst, MD, University of Pittsburgh Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Goal Directed Therapy
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 .