Outcome of intraoperative goal-directed therapy using Vigileo/FloTrac in high-risk patients scheduled for major abdominal surgeries: A prospective randomized trial

Peer review under responsibility of Egyptian Society of Anesthesiologists.

Figures & data

Fig. 1 Protocol algorithm of the GDT group.

Fig. 2 Flow of participants through the study.

Table 1 Demographic data of patients of both groups.

Data	Group		CT (n = 43)	GDT (n = 43)	P value
Age (years)			57 ± 8.5	58 ± 6.6	0.550
Sex; M:F ratio			27:16	24:19	0.510
BMI data	Weight (kg)		85.8 ± 7.8	87 ± 8.9	0.504
	Height (cm)		170.2 ± 3.3	170.4 ± 3.1	0.811
	BMI (kg/m^2)		29.6 ± 2.7	30 ± 3.1	0.576
ASA grade	ASA-II		19 (44.2%)	18 (41.9%)	0.828
	ASA-III		24 (55.8%)	25 (58.1%)
Lee Revised Cardiac Risk Index	Class I		13 (30.2%)	11 (25.6%)	0.938
	Class II		18 (41.9%)	17 (39.5%)
	Class III		7 (16.3%)	9 (20.9%)
	Class IV		5 (11.6%)	6 (14%)
Associated co-morbidities	Yes	Diabetes Mellitus	14 (32.6%)	11 (25.6%)
		Hypertension	7 (16.2%)	5 (11.6%)
		Ischemic heart disease	3 (7%)	2 (4.7%)
		Multiple	8 (18.6%)	16 (37.2%)
		Total	32 (74.4%)	34 (79.1%	0.439
	No		11 (25.6%)	9 (20.9%)
Assigned surgical procedure	Hepatectomy		13 (30.2%)	17 (39.5%)	0.782
	Whipple pancreatico-duodenectomy		5 (11.6%)	3 (7%)
	Colectomy		16 (37.2%)	15 (34.9%)
	Spleenectomy		3 (7%)	2 (4.7%)
	Total abdominal hysterectomy with bilateral salpingo-oopherectomy		4 (9.3%)	5 (11.6%)
	Resection of retroperitoneal tumors		2 (4.7%)	1 (2.3%)

Data are presented as mean ± SD, ratio & numbers; percentages are in parenthesis; BMI: Body mass index; p > 0.05: indicates non-significant difference.

Table 2 Intraoperative data of patients of both groups.

Data	Group			CT (n = 43)	GDT (n = 43)	P value
Time lapse till conduction of surgery (min)				62 ± 11.8	65 ± 15.4	0.313
Operative time (min)				232.4 ± 30.6	227.6 ± 24.3	0.433
Blood loss (ml)				750 ± 304	690 ± 226	0.310
Transfused blood products	PRC	Frequency	No	10 (23.3%)	19 (44.2%)	0.189
			Received	33 (76.7%)	24 (55.8%)
		Amount (unit)		1.07 ± 0.8	0.74 ± 0.78	0.066
	FFP	Frequency	No	26 (60.5%)	22 (51.2%)	0.633
			Received	17 (39.5%)	21 (48.8%)
		Amount (unit)		0.58 ± 0.8	0.8 ± 0.9	0.231
FT	Crystalloid			1988 ± 320	658.5 ± 104.6	0.001^*
	Colloid			331.4 ± 216.3	1442.7 ± 359	0.001^*
	Total			2320.2 ± 402.1	2102.1 ± 444.8	0.019^*
Nor-epinephrine infusion			Received	6 (14%)	2 (4.7%)	0.138
			No	37 (86%)	41 (95.3%)
Dobutamine infusion			Received	2 (4.7%)	3 (7%)	0.645
			No	41 (95.3%)	40 (93%)

Data are presented as mean ± SD, numbers; percentages are in parenthesis; FT: Fluid therapy; p < 0.05: indicates significant difference; p > 0.05: indicates non-significant difference.

* denotes significant difference.

Table 3 Intraoperative hemodynamic and UOP data of patients of both groups.

Parameter	Group	Time-0	Time-30	Time-60	Time-90	Time-120	Time-150	Time-180	Time-210	Time-240	Time-270
MAP (mmHg)	CT	94.4 ± 3	73.1 ± 5.4	75 ± 4.4	71.7 ± 5	73.6 ± 5.1	71.8 ± 5	73.2 ± 4.6	73 ± 4.6	76 ± 4.6	75.1 ± 4.4
	GDT	94 ± 3.8	72.3 ± 5.4	75.8 ± 4.9	74 ± 4.5	73 ± 3.9	74.1 ± 4.3	74.6 ± 4	75.4 ± 4	75.8 ± 5.3	75.8 ± 3.4
	P value	0.698	0.723	0.867	0.266	0.786	0.088	0.298	0.067	0.873	0.621
CVP (mmHg)	CT	10.3 ± 1.7	10 ± 1.5	9.6 ± 1.9	8.6 ± 1.4	8.3 ± 1.3	8.9 ± 1.7	8.5 ± 1	8.6 ± 1	8.5 ± 1.2	10 ± 1.5
	GDT	10.1 ± 1.8	9.9 ± 1.4	9.3 ± 1.6	8.7 ± 1.5	8.5 ± 1.4	8.6 ± 1	8.6 ± 0.9	8.7 ± 0.8	8.9 ± 1.6	10.1 ± 1.7
	P value	0.247	0.294	0.089	0.437	0.163	0.093	0.323	0.432	0.078	0.607
HR (beats/min)	CT	88.6 ± 6.7	78.9 ± 5.6	86.7 ± 4.1	84 ± 6.1	82 ± 4.9	81 ± 6.1	86 ± 2.9	82.5 ± 3.8	87 ± 3.7	79.8 ± 3.4
	GDT	83 ± 4.6	81.8 ± 4.3	85.2 ± 3.6	89 ± 4.2	79.7 ± 5.8	85 ± 3.1	87.7 ± 4.8	79 ± 6.1	83.8 ± 5.2	77.4 ± 5.1
	P value	0.487	0.368	0.751	0.487	0.327	0.181	0.637	0.425	0.654	0.365
UOP (ml/kg/h)	CT	0.61 ± 0.02	0.54 ± 0.03	0.58 ± 0.02	053 ± 0.03	0.64 ± 0.05	0.67 ± 0.07	0.48 ± 0.02	0.54 ± 0.08	0.58 ± 0.07	0.52 ± 0.04
	GDT	0.65 ± 0.04	0.55 ± 0.08	0.6 ± 0.03	0.54 ± 0.06	0.63 ± 0.1	0.64 ± 0.05	0.51 ± 0.03	0.58 ± 0.04	0.62 ± 0.04	0.55 ± 0.06
	P value	0.614	0.543	0.295	0.874	0.781	0.307	0.298	0.209	0.308	0.374

Data are shown as mean ± SD value; MAP: Mean arterial pressure; CVP: Central venous pressure; HR: Heart rate; UOP; urine output; Time-0 : time of starting surgical procedure; UOP at T0 indicated rate of UOP since 8 AM(post-voiding) till start of surgery, collected once patient was catheterized; p > 0.05: indicates non-significant difference.

Table 4 ICU fluid therapy and medication received by patients of both group during the 1st 24-h ICU stay.

Data		CT (n = 43)	GDT (n = 43)	P value
FT	Crystalloid	3088.5 ± 275	2610 ± 265	0.001^*
	Colloid	288.5 ± 90	327.2 ± 104.5	0.301
	Total	3175.7 ± 358	2755 ± 408	0.001^*
PRC		1 (2.3%)	2 (4.6%)	0.557
Nor-epinephrine infusion		5 (11.6%)	2 (4.6%)	0.237
Dobutamine infusion		2 (4.6%)	3 (7%)	0.645

Data are presented as mean ± SD; CT: Conventional fluid therapy; GDT: Goal-directed fluid therapy; PRC: Packed Red Cells; p value indicates significance of difference between CT and GDT groups.

Table 5 Mean blood lactate levels estimated throughout 1st 24-h ICU stay compared to preoperative levels:

Time	Group	Blood lactate level (mmol/L)	P value
Preoperative	CT	0.675 ± 0.35	0.694
	GDT	0.645 ± 0.33
At ICU admission	CT	3.12 ± 0.75^*	0.001
	GDT	1.18 ± 0.38^*
6-h after ICU admission	CT	2.58 ± 0.77^*^,^†	0.001
	GDT	0.98 ± 0.45^*
12-h after ICU admission	CT	1.38 ± 0.26^*^,^†^,^‡	0.001
	GDT	0.9 ± 0.39^*^,^‡
18-h after ICU admission	CT	1.09 ± 0.45^*^,^†^,^‡	0.001
	GDT	0.83 ± 0.26^‡
24-h after ICU admission	CT	0.98 ± 0.38^†^,^‡^,^¶	0.004
	GDT	0.73 ± 0.38^‡^,^¶

Data are presented as mean ± SD; CT: Conventional fluid therapy; GDT: Goal-directed fluid therapy; P value <0.05: indicates significant difference between CT and GDT groups.

* Significance versus preoperative levels.

† Significance versus at admission levels.

‡ Significance versus at 6-h levels.

¶ Significance versus at 12-h levels

Table 6 Outcome of patients of both groups.

Data	Group			CT (n = 43)	GDT (n = 43)	P value
Predicted morbidity according to POSSUM score				42.86%	39.78%	0.706
PO events	During ICU stay	Need for MV	Frequency	8 (18.5%)	2 (4.6%)	0.044
			Duration (hr)	2.3 ± 0.4	1.5 ± 0.5	0.767
		PO bleeding required	Conservation	1 (2.3%)	2 (4.6%)	0.557
			Re-opening	1 (2.3%)	1 (2.3%)	1
			Total	2 (4.6%)	3 (7%)	0.645
		Need for RRT	Frequency	4 (9.3%)	2 (4.6%)	0.397
			Serum Cr. (mg/dl)	6.3 ± 1.1	6.2 ± 1	0.9
		Acute myocardial infarction		3 (7%)	0	0.078
		Number of affected patients		9 (20.9%)	4 (9.3%)	0.039
	During ward stay	Intestinal leakage		0	1 (2.3%)	0.256
		Abdominal sepsis		3 (7%)	1 (2.3%)
		Delayed wound healing		7 (16.3%)	2 (4.6%)
		Total		10 (23.3%)	4 (9.3%)	0.080
		Number of affected patients		7 (16.3%)	3 (7%)	0.067
	Total number of affected patients			16 (37.2%)	7 (16.3%)	0.028
ICU re-admission rate				3 (7%)	1 (2.3%)	0.308
Length of stay (Days)		ICU		3.5 ± 1.4^*	2.3 ± 0.9	0.001^*
		Total hospital		12.2 ± 3.5	9.7 ± 1.9	0.071
Predicted mortality according to POSSUM score				12.56%	11.34%	0.606
Mortality rate		ICU		2 (4.6%)	1 (2.3%)	0.557
		Total hospital		5 (11.6%)	3 (7%)	0.479

Data are presented as mean± SD, numbers; percentages are in parenthesis; POSSUM: The Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity FT: Fluid therapy; PRC: Packed Red Cells; PO: Postoperative; MV: Mechanical ventilation; RRT: Renal replacement therapy; Cr.: creatinine; p<0.05: indicates significant difference.

* denotes significant difference.