Complications were observed less frequently in patients treated by the protocol in both series (Table 8). Both the proportion of patients who had complications and the average number of complications per patient were lowest in the PA-protocol group (p<0.05). There was a higher incidence of patients with multiple complications in the control group of both series. There were 17 patients (57 percent) in the CVP group who in the opinion of the primary service developed indications for PA catheterization for management in the postoperative period; seven (29 percent) of these patients subsequently died.
Of the 55 patients in the second series who fulfilled the entrance criteria but were not randomized, ten were operated on immediately; four of these died. This group was too small for further statistical analysis. The remaining 45 patients (NR group) were not considered sufficiently ill in the opinions of their primary service resident and attending staff to warrant invasive monitoring and declined the study. Ironically, despite the initial reluctance, 27 (60 percent) of these patients subsequently had a PA catheter placed by their primary service, usually after they developed lethal postoperative complications. This nonrandomized, nonemergency group had the highest mortality and morbidity (Tables 7 and 8).
Table 6 compares mortality of patients whose monitoring was begun preoperatively with that of patients whose monitoring was started postoperatively in the first series. The data is stratified in those with normal, high, and low preoperative Cl values. Table 9 summarizes the mortality rates for both series and the intervening control periods over a 7y2-year study.
There were transient dysrhythmias (almost always premature ventricular complexes) on insertion of the PA catheter in 12 percent, local infection or inflammation at the catheter site in 5 percent, and positive blood cultures drawn from the PA catheters in 44 percent of the septic patients. There were no major or permanent complications that could be attributed to the PA catheters.
The hospital charges in the second series averaged $31,438 for patients in the nonrandomized group, $30,748 for the CVP group, $37,335 for the PA-control group and $27,665 for the PA-protocol group. The average patient expenditure distributed over the survivors was $50,525 for the nonrandomized group, $40,106 for the CVP group, $58,950 for the PA-control group and $28,690 in the PA-protocol group.
|Series 1||Series 2|
|Control (N = 151)||Protocol (N = 101)||Nonrandomized (N = 45)||CVP-Control (N = 30)||PA-Control (N = 30)||PA-Protocol (N = 28)|
|Complications in the therapeutic groups|
|Sepsis and septic shock||44||23||11||6||9|
|Gastric outlet obstruction||0||0||1|
|Urinary tract infection||0||0||1||1|
|No. of complications||232||98*||52||31||39||11*|
|Complications per patient||1.54||0.97||1.16||1.03||1.3||0.39|
|Frequency of multiple complications|
|Patients with complications||99 (66%)||61 (61%)||28 (62%)||15 (50%)||15 (50%)||8 (28%)t|
|Patients with 0 complications||52 (34%)||40 (39%)||17 (38%)||15 (50%)||15 (50%)||20 (71%)|
|Patients with 1 complication||42 (28%)||38 (38%)||13 (29%)||7 (23%)||3 (10%)||5 (18%)|
|Patients with 2 complications||21 (14%)||14 (14%)||8 (18%)||3 (10%)||4 (13%)||3 (11%)|
|Patients with 3 complications||20 (13%)||6 (6%)||5 (11%)||2 (7%)||4 (13%)||0|
|Patients with 4 or more complications||15 (10%)||3 (3%)||2 (4%)||3 (10%)||4 (13%)||0|
Table 9—Summary of Mortality of the Prospective Series
|Series 1||1/78-6/80||168||57 (34%)||108||21 (19%)|
|Control period between trials||6/80-5/83||239||66 (28%)|
|Series 2||5/83-5/84||105||34 (32%)||28||1 (4%)|
|Control period after trials||5/84-5/85||160||40 (25%)|
|Total||672||197 (29%)||136||22 (16%)|
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