Table 2.
Clinical management of participants during intervention period (during and for four hours after surgery). Values are number (percentage) unless stated otherwise
| Summary measure | ||
|---|---|---|
| Intervention (n=1251) | Usual care (n=1247) | |
| Characteristics of surgery | ||
| Median (IQR) duration of surgery (mins) | 259.5 (180-357) | 265 (187-365) |
| Type of surgical procedure: | ||
| Resection of colon, rectum, or small bowel | 895 (71.5) | 888 (71.2) |
| Resection of pancreas and bowel | 118 (9.4) | 115 (9.2) |
| Resection of stomach (non-obesity surgery) | 87 (7.0) | 84 (6.7) |
| Resection of oesophagus (non-obesity surgery) | 32 (2.6) | 31 (2.5) |
| Obesity surgery | 7 (0.6) | 6 (0.5) |
| Other major surgery involving gut resection | 99 (7.9) | 114 (9.1) |
| Surgical technique: | ||
| Open surgical | 537 (42.9) | 545 (43.7) |
| Laparoscopic or laparoscopic assisted | 607 (48.5) | 603 (48.4) |
| Laparoscopic converted to open | 100 (8.0) | 93 (7.5) |
| Cardiac output monitor sensor used: | ||
| ClearSight | 236 (18.9) | 11 (0.9) |
| FloTrac | 970 (77.5) | 2 (0.2) |
| Other | 5 (0.4) | 4 (0.3) |
| Anaesthetic technique: | ||
| General anaesthesia | 1248 (99.8)* | 1247 (100) |
| Spinal/epidural | 682 (54.5) | 649 (52.0) |
| Tracheal tube removed at end of surgery | 1165 (93.1) | 1188 (95.3) |
| Median (IQR) time in post-anaesthesia care unit post-surgery (mins) | 240 (60-300) | 180 (60-300) |
| Haemodynamic therapy intervention stopped before 4 hours post-surgery? | 59 (4.7) | NA |
| Level of care on first night post-surgery†: | ||
| Critical care level 3 | 115 (9.2) | 91 (7.2) |
| Critical care level 2 | 607 (48.5) | 607 (48.7) |
| Post-anaesthesia care unit | 159 (12.7) | 162 (13.0) |
| Surgical ward | 364 (29.1) | 388 (31.1) |
| Fluids during surgery | ||
| Primary fluid used for volume replacement: | ||
| Balanced crystalloid‡ | 1156 (92.6) | 1137 (91.2) |
| 0.9% sodium chloride | 37 (3.0) | 44 (3.5) |
| Gelatin based colloid | 10 (0.8) | 5 (0.4) |
| Starch based colloid | 29 (2.3) | 28 (2.3) |
| Albumin | 4 (0.3) | 0 (0.0) |
| Other | 13 (1.0) | 33 (2.7) |
| Mean (SD) total intravenous crystalloid (mL) | 2407 (1810) | 2307 (1525) |
| Mean (SD) total intravenous colloid (mL) | 93 (278) | 64 (239) |
| Received any colloid: No (%), mean (SD) volume (mL) | 176 (14.1), 661 (418) | 147 (11.8), 547 (469) |
| Mean (SD) total red cell and other blood products (mL) | 73 (555) | 56 (373) |
| Received any red cell and other blood products: No (%), mean (SD) volume (mL) | 114 (9.1), 802 (1679) | 96 (7.7), 731 (1154) |
| Mean (SD) total volume of all fluids (mL) | 2573 (2137) | 2428 (1677) |
| Fluids four hours after surgery | ||
| Primary fluid used for volume replacement: | ||
| Balanced crystalloid | 1005 (80.5) | 908 (73.1) |
| 0.9% sodium chloride | 64 (5.1) | 95 (7.6) |
| Gelatin based colloid | 6 (0.5) | 3 (0.2) |
| Starch based colloid | 7 (0.6) | 4 (0.3) |
| Albumin | 5 (0.4) | 1 (0.1) |
| Other | 4 (0.3) | 9 (0.7) |
| None | 158 (12.7) | 223 (17.9) |
| Mean (SD) total intravenous crystalloid after surgery (mL) | 638 (718) | 565 (770) |
| Mean (SD) total intravenous colloid after surgery (mL) | 31 (417) | 34 (495) |
| Received any colloid after surgery, No (%), mean (SD) volume (mL) | 38 (3.0), 1016 (2204) | 36 (2.9), 1181 (2704) |
| Mean (SD) total red cell and other blood products after surgery (mL) | 26 (409) | 31 (493) |
| Received any red cell and other blood products after surgery, No (%), mean (SD) volume (mL) | 27 (2.2), 1191 (2568) | 27 (2.2), 1447 (3090) |
| Mean (SD) total volume of all fluids after surgery (mL) | 695 (1336) | 630 (1575) |
| Drugs used during intervention period | ||
| Inotrope infusion: | ||
| Dobutamine | 1176 (94.0) | 6 (0.5) |
| Dopexamine | 0 (0.0) | 0 (0.0) |
| Neither | 68 (5.4) | 1241 (99.5) |
| Infusion rate reduced due to tachycardia: | ||
| Yes (during surgery) | 166 (13.3) | 1 (0.1) |
| Yes (after surgery) | 83 (6.6) | 1 (0.1) |
| No | 915 (78.6) | 11 (84.6) |
| Bolus vasopressor or inotrope agent used during intervention period§ | 813 (65.0) | 793 (63.6) |
| Infusion of vasopressor or inotrope (other than intervention mandated fixed dose dopexamine or dobutamine) during intervention period: | 505 (40.4) | 554 (44.4) |
| Inotrope infusion | 8 (0.6) | 12 (1.0) |
| Vasopressor infusion | 504 (40.3) | 547 (43.8) |
| Additional research staff present to assist with trial intervention during surgery | 653 (52.2) | 142 (11.4) |
| Additional research staff present to assist with trial intervention in four hours post-surgery | 527 (42.1) | 81 (6.5) |
IQR=interquartile range; NA=not applicable; SD=standard deviation.
Missing data for three participants. All patients are assumed to have received general anaesthesia owing to extent of surgery
Levels of care are defined according to care the patient receives: Critical care level 3: includes advanced organ support (eg, invasive ventilation, renal replacement therapy). Critical care level 2: might include advanced cardiorespiratory monitoring (eg, invasive arterial/central venous monitoring) and basic organ support (eg, non-invasive ventilation, inotropic/vasoactive drugs). Post-anaesthetic care unit: designated area for patient care immediately after anaesthesia. Surgical ward (level 0/1): normal ward care without capability for level 2 or 3 interventions or monitoring.
Balanced crystalloids included compound sodium lactate/Ringer’s solution/Hartmann’s solution, Plasmalyte 148, and Normosol-R.
Inotropes were defined as any of epinephrine (adrenaline), ephedrine, dobutamine, dopexamine, or dopamine. Vasopressors were defined as any of metaraminol, phenylephrine, or norepinephrine (noradrenaline).