OBJECTIVES: To compare neonates receiving arterial switch operation (ASO) either with mild or moderate hypothermic cardiopulmonary bypass. METHODS:Forty neonates undergoing ASO were randomized to receive either mild (Mi > 32 °C, n = 20) or moderate (Mo > 26 °C, n = 20) hypothermic cardiopulmonary bypass (CPB) between April 2007 and June 2010. All patients were diagnosed with simple transposition of the great arteries. Mean age (Mi: 8.32 ± 4.5 days, Mo: 7.54 ± 5.0 days, P = 0.21) and body weight were similar in both groups (Mi: 3.64 ± 0.91 kg, Mo: 3.73 ± 0.84 kg, P = 0.14). Follow-up was 3.1 ± 2.5 years for all patients. RESULTS:Lowest perioperative rectal temperature was 33.5 ± 1.4 °C (Mi) versus 28.2 ± 2.1 °C (Mo) (P < 0.001). All patients safely weaned from CPB required lower doses of dopamine (Mi: 5.1 ± 2.4 µg/kg min, Mo: 6.5 ± 2.1 µ/kg min, P = 0.04), dobutamine (Mi: 7.2 ± 2.5 µg/kg min, Mo: 8.6 ± 2.4 µ/kg min, P = 0.04) and adrenalin (Mi: 0.02 ± 0.02 µg/kg min, Mo: 0.05 ± 0.03 µ/kg min, P = 0.03) in mild hypothermia group. Intraoperative blood transfusion (Mi: 190 ± 58 ml, Mo: 230 ± 24 ml, P = 0.03) and postoperative lactate levels (Mi: 2.7 ± 0.9 mmol/l, Mo: 3.1 ± 2.2 mmol/l, P = 0.02) were lower under mild hypothermia. Secondary chest closure was performed in 30% (Mi) versus 35% (Mo) (P = 0.65). Duration of inotropic support (Mi: 7 (4-11) days, Mo: 11 (7-15) days, P = 0.03), time to extubation (Mi: 108 (88-128) h, Mo: 128 (102-210) h, P = 0.04), lengths of intensive care unit (ICU) stay (Mi: 9 (5-14) days, Mo: 12 (10-18) days, P = 0.04) and hospital stay (Mi: 19 (10-29) days, Mo: 23 (15-37) days, P = 0.04) were significantly shorter under mild hypothermia. Two-year freedom from reoperation was 100% for both the groups. CONCLUSIONS: The ASO under mild hypothermia seemed to be beneficial for pulmonary recovery, need for inotropic support and length of ICU and hospital stay. No worse early- or intermediate-term effects of mild hypothermia were found.
RCT Entities:
OBJECTIVES: To compare neonates receiving arterial switch operation (ASO) either with mild or moderate hypothermic cardiopulmonary bypass. METHODS: Forty neonates undergoing ASO were randomized to receive either mild (Mi > 32 °C, n = 20) or moderate (Mo > 26 °C, n = 20) hypothermic cardiopulmonary bypass (CPB) between April 2007 and June 2010. All patients were diagnosed with simple transposition of the great arteries. Mean age (Mi: 8.32 ± 4.5 days, Mo: 7.54 ± 5.0 days, P = 0.21) and body weight were similar in both groups (Mi: 3.64 ± 0.91 kg, Mo: 3.73 ± 0.84 kg, P = 0.14). Follow-up was 3.1 ± 2.5 years for all patients. RESULTS: Lowest perioperative rectal temperature was 33.5 ± 1.4 °C (Mi) versus 28.2 ± 2.1 °C (Mo) (P < 0.001). All patients safely weaned from CPB required lower doses of dopamine (Mi: 5.1 ± 2.4 µg/kg min, Mo: 6.5 ± 2.1 µ/kg min, P = 0.04), dobutamine (Mi: 7.2 ± 2.5 µg/kg min, Mo: 8.6 ± 2.4 µ/kg min, P = 0.04) and adrenalin (Mi: 0.02 ± 0.02 µg/kg min, Mo: 0.05 ± 0.03 µ/kg min, P = 0.03) in mild hypothermia group. Intraoperative blood transfusion (Mi: 190 ± 58 ml, Mo: 230 ± 24 ml, P = 0.03) and postoperative lactate levels (Mi: 2.7 ± 0.9 mmol/l, Mo: 3.1 ± 2.2 mmol/l, P = 0.02) were lower under mild hypothermia. Secondary chest closure was performed in 30% (Mi) versus 35% (Mo) (P = 0.65). Duration of inotropic support (Mi: 7 (4-11) days, Mo: 11 (7-15) days, P = 0.03), time to extubation (Mi: 108 (88-128) h, Mo: 128 (102-210) h, P = 0.04), lengths of intensive care unit (ICU) stay (Mi: 9 (5-14) days, Mo: 12 (10-18) days, P = 0.04) and hospital stay (Mi: 19 (10-29) days, Mo: 23 (15-37) days, P = 0.04) were significantly shorter under mild hypothermia. Two-year freedom from reoperation was 100% for both the groups. CONCLUSIONS: The ASO under mild hypothermia seemed to be beneficial for pulmonary recovery, need for inotropic support and length of ICU and hospital stay. No worse early- or intermediate-term effects of mild hypothermia were found.
Authors: Ivan Urits; Mark R Jones; Vwaire Orhurhu; Andrew Sikorsky; Danica Seifert; Catalina Flores; Alan D Kaye; Omar Viswanath Journal: Adv Ther Date: 2019-07-12 Impact factor: 3.845