Goal-Directed Therapy in Cancer Surgery | NCT01946269 | Trialant

Goal-Directed Therapy in Cancer Surgery | NCT01946269 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard group	Active Comparator		Other: Standard protocol
Goal-directed therapy (GDT) protocol	Active Comparator		Other: Goal-directed Resuscitation Therapy (GDT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Goal-directed Resuscitation Therapy (GDT)	Other	A target value of a cardiac index (CI) greater than 2.5 L/min/m2 and a mean arterial pressure of 70 mmHg will be sought. The first step will be fluid resuscitation with 200ml aliquots of Lactated Ringer's solution plus human albumin 20% 50 mL whenever the CI is lower than 2.5 L/min/m2. The fluid challenge will be stopped if the CVP rises by more than 4 mmHg during the infusion period or CI increases less than 10%. When the CI is lower than or equal to 2.5L/min/m2 despite of fluid challenge, dobutamine will be initiated with increasing doses up to 20mcg/kg/min. The final step will be red blood transfusion to reach a hematocrit higher than 28%. If necessary, norepinephrine infusion will be used to maintain a mean arterial pressure above 70 mmHg.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite endpoint of death or major postoperative complications	Death or one of the following complications: stroke, renal failure, respiratory complications, cardiovascular complications, deep wound infection and reoperation for any reason.	30 days after randomization

Secondary Outcomes

Measure	Description	Time Frame
Duration of ICU stay and hospital stay	To compare the number of days of ICU stay and hospital stay between groups.	30 days after randomization
Tissue hypoperfusion markers	To compare levels of DO2, lactate, ScvO2, base excess and venous to arterial carbon dioxide difference between groups.

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29792232	Derived	Gerent ARM, Almeida JP, Fominskiy E, Landoni G, de Oliveira GQ, Rizk SI, Fukushima JT, Simoes CM, Ribeiro U Jr, Park CL, Nakamura RE, Franco RA, Candido PI, Tavares CR, Camara L, Dos Santos Rocha Ferreira G, de Almeida EPM, Filho RK, Galas FRBG, Hajjar LA. Effect of postoperative goal-directed therapy in cancer patients undergoing high-risk surgery: a randomized clinical trial and meta-analysis. Crit Care. 2018 May 23;22(1):133. doi: 10.1186/s13054-018-2055-4.