RCT effect of peri-operative GDHT on cardiac surgery outcomes

Patient Population
Cardiac surgery.

LiDCO Monitor
LiDCOrapid goal-directed therapy (GDT) targeted cardiac index (CI).

Trial Design
Randomised GDT targeted cardiac index vs standard care.

Outcome Impact
Composite endpoint 30-day mortality and major postoperative complications reduced in the goal-directed therapy group (27.4% vs 45.3%) and GDT patients had less infections (12.9% vs 29.7%), a lower incidence of low cardiac output syndrome (6.5% vs 26.6%), reduced ICU (3 vs 5 days) and hospital stay (9 vs 12 days).

OBJECTIVES
To evaluate the effects of goal-directed therapy on outcomes in high-risk patients undergoing cardiac surgery.

DESIGN:
A prospective randomised controlled trial and an updated meta-analysis of randomised trials published from inception up to May 1, 2015.

SETTING
Surgical ICU within a tertiary referral university-affiliated teaching hospital.

PATIENTS
One hundred twenty-six high-risk patients undergoing coronary artery bypass surgery or valve repair.

INTERVENTIONS
Patients were randomized to a cardiac output-guided hemodynamic therapy algorithm (goal-directed therapy group, n = 62) or to usual care (n = 64). In the goal-directed therapy arm, a cardiac index of greater than 3 L/min/m was targeted with IV fluids, inotropes, and RBC transfusion starting from cardiopulmonary bypass and ending 8 hours after arrival to the ICU.

MEASUREMENTS AND MAIN RESULTS
The primary outcome was a composite endpoint of 30-day mortality and major postoperative complications. Patients from the goal-directed therapy group received a greater median (interquartile range) volume of IV fluids than the usual care group (1,000 [625-1,500] vs 500 [500-1,000] mL; p < 0.001], with no differences in the administration of either inotropes or RBC transfusions. The primary outcome was reduced in the goal-directed therapy group (27.4% vs 45.3%; p = 0.037). The goal-directed therapy group had a lower occurrence rate of infection (12.9% vs 29.7%; p = 0.002) and low cardiac output syndrome (6.5% vs 26.6%; p = 0.002). We also observed lower ICU cumulative dosage of dobutamine (12 vs 19 mg/kg; p = 0.003) and a shorter ICU (3 [3-4] vs 5 [4-7] d; p < 0.001) and hospital length of stay (9 [8-16] vs 12 [9-22] d; p = 0.049) in the goal-directed therapy compared with the usual care group. There were no differences in 30-day mortality rates (4.8% vs 9.4%, respectively; p = 0.492). The metaanalysis identified six trials and showed that, when compared with standard treatment, goal-directed therapy reduced the overall rate of complications (goal-directed therapy, 47/410 [11%] vs usual care, 92/415 [22%]; odds ratio, 0.40 [95% CI, 0.26-0.63]; p < 0.0001) and decreased the hospital length of stay (mean difference, -5.44 d; 95% CI, -9.28 to -1.60; p = 0.006) with no difference in post-operative mortality: 9 of 410 (2.2%) versus 15 of 415 (3.6%), odds ratio, 0.61 (95% CI, 0.26-1.47), and p = 0.27.

CONCLUSIONS
Goal-directed therapy using fluids, inotropes, and blood transfusion reduced 30-day major complications in high-risk patients undergoing cardiac surgery.

Osawa EA, Rhodes A, Landoni G, Galas FR, et al. Effect of Perioperative Goal-Directed Hemodynamic Resuscitation Therapy on Outcomes Following Cardiac Surgery: A Randomized Clinical Trial and Systematic Review. Crit Care Med. 2016;44(4):724-33. doi: 10.1097/CCM.0000000000001479.

Study showed composite endpoint 30-day mortality and major post-operative complications reduced in the goal-directed therapy group (27.4% vs 45.3%) and GDT patients had less infections (12.9% vs 29.7%), a lower incidence of low cardiac output syndrome (6.5% vs 26.6%), reduced ICU (3 vs 5 days) and hospital stay (9 vs 12 days).