Goal-Directed Therapy in Cancer Surgery (GRICS II)
|ClinicalTrials.gov Identifier: NCT01946269|
Recruitment Status : Unknown
Verified September 2013 by Ludhmila Abrahão Hajjar, University of Sao Paulo.
Recruitment status was: Recruiting
First Posted : September 19, 2013
Last Update Posted : September 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Care||Other: Goal-directed Resuscitation Therapy (GDT) Other: Standard protocol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Goal-directed Resuscitation in High-risk Patients Undergoing Major Cancer Surgery: a Controlled and Randomized Study|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||May 2014|
|Active Comparator: Standard group||
Other: Standard protocol
The control group will be managed by the surgical ICU staff in the postoperative period according to institutional protocol of hemodynamic monitoring.
|Active Comparator: Goal-directed therapy (GDT) protocol||
Other: Goal-directed Resuscitation Therapy (GDT)
- Composite endpoint of death or major postoperative complications [ Time Frame: 30 days after randomization ]Death or one of the following complications: stroke, renal failure, respiratory complications, cardiovascular complications, deep wound infection and reoperation for any reason.
- Duration of ICU stay and hospital stay [ Time Frame: 30 days after randomization ]To compare the number of days of ICU stay and hospital stay between groups.
- Tissue hypoperfusion markers [ Time Frame: 7 days after randomization ]To compare levels of DO2, lactate, ScvO2, base excess and venous to arterial carbon dioxide difference between groups.
- Daily SOFA score [ Time Frame: 7 days after randomization ]Daily sequential organ failure assessment score within the first 7 days after randomization
- Cardiovascular complications [ Time Frame: 30 days after randomization ]To compare the incidence of cardiovascular complications between groups. Cardiovascular complications will be defined as myocardial ischemia, acute decompensated heart failure, mesenteric ischemia, pulmonary thromboembolism and peripheral vascular ischemia.
- Respiratory complications [ Time Frame: 30 days after randomization ]Respiratory complication will be defined as acute distress respiratory syndrome according to Berlin criteria
- Severe Renal complication [ Time Frame: 30 days after randomization ]Severe renal complication will be defined as renal failure according to Acute Kidney Injury Network (AKIN) stage 3.
- Neurological complications [ Time Frame: 30 days after randomization ]To compare the incidence of stroke between groups within 30 days after randomization.
- Severe infectious complications [ Time Frame: 30 days after randomization ]To compare the incidence, between groups, of infectious complications defined as a new septic shock.
- Surgical complications [ Time Frame: 30 days after randomization ]To compare the incidence between groups of surgical complication. Surgical complication will be defined as reoperation due to any reason, hospital readmission or death
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946269
|Contact: Aline Müller, MDemail@example.com|
|Intensive Care Unit of the Cancer Institute of Sao Paulo State||Recruiting|
|Sao Paulo, SP, Brazil, 01246000|
|Contact: Aline Müller, MD 55-11-974130225 firstname.lastname@example.org|
|Principal Investigator: Aline Müller, MD|
|Principal Investigator: Ludhmila Hajjar, MD, PhD|