Prospective Trial of Supranormal Values of Survivors as Therapeutic Goals in High-Risk Surgical Patients: Outcome Data

In: Surgical Patients

14 Mar 2015

Outcome Data
Table 6 summarizes the outcome data of the control and protocol groups of the first series which had sufficient numbers of patients to stratify into clinical subgroups. There were 168 operations on 151 control patients, 57 (38 percent) of whom died and 108 operations on 101 protocol patients, 21 (21 percent) of whom died (p<0.05). The data of each subgroup are listed in Table 6 and in general show improved mortality in protocol patients in subgroups with sufficient numbers. In series 1, seven of the 67 protocol patients with normal preoperative values dfed; three of these patients had delayed insertion of their PA catheters that averaged 56 h after the end of their operation. Five patients had overwhelming medical problems: one patient had massive intraoperative blood loss associated with delayed transfusion. cheap wellbutrin

An 82-year-old man had perforated gastric cancer with widespread metastases and peritonitis. An 80-year-old man had postoperative hemorrhage after abdominoperineal resection for rectal cancer, which necessitated subsequent surgery that led to peritonitis, severe hemorrhagic pancreatitis with ARDS and cardiac arrest. Finally, an 81-year-old woman had peritonitis following resection of a gangrenous infarcted ileal segment. Three of these patients had delayed or inadequate fluid administration and their management was in poor compliance with the protocol.
Table 7 summarizes the outcome data of series 2. The mortality rates were: 23 percent for the CVP-control group, 33 percent for the PA-control group, and 4 percent for the PA-protocol group. The single death in the protocol group was that of a 67-year-old man scheduled for esophagogastrectomy who at operation was found to have carcinomatosis and all that was done was a biopsy and closure. He died two weeks later of cancer, but because he did not leave the hospital alive, he was considered a protocol failure. The difference in the mortality rates was statistically significant when the PA-protocol group was compared with the PA-control group (4 vs 33 percent, p<0.01), as well as with both CVP plus PA-control groups (4 vs 28 percent, p<0.02); it was marginally significant when the PA-protocol group was compared with the CVP-control group (4 vs 23 percent, p<0.10); the CVP group mortality was not significantly different from that of the PA-control group (23 vs 33 percent, p<0.20).
Table 6—Comparison of Mortality in Subgroup of Control and Protocol Patients Whose Studies Were Started Preoperatively with Those Whose Studies Were Started Postoperatively

Control Group Protocol Group Total
Started Preopt StartedPostopt Subtotal Started Preop Started Postop Subtotal
No. Died % No. Died % No. Died % No. Died % No. Died % No. Died % No. Died %
Normal preop values 79 21|| 27 39 12 31 118 3311 28 42 4|| 9.5 25 3 12 67 7f 10 185 40 22
Septic/Cirrhotic (CI>4 L/min#m2) 18 9 50 7 5 71 25 14 56 15 3 20 7 3 43 22 6 27 47 20 43
Severe trauma/stress (CI>4 L/min*m2) 9 1 11 13 6 46 22 7 32 13 4 31 2 1 50 15 5 33 37 12 32
Elderly/hemorrhage (CI<2.4 L/minnn2) 0 0 0 2 2 100 2 2 100 3 2 67 0 0 0 3 2 67 5 4 80
Miscellaneous§ 1 1 100 0 0 0 1 1 100 0 0 0 1 1 100 1 1 100 2 2 100
Total 107 32 30 61 25 41 168 57H 34 73 13 18 35 8 23 108 2111 19 276 78 28

Table 7—Summary qf Clinical Data of Series 2

Non randomized (N = 45) CVP-Control(N = 30) PA-Control(N =30) PA-Protocol (N = 28)
Age, yr 56.9±2.5 55.2±3.0 53.4±2.5 56.4 ±3.1
Sex, males/females (%) 45/55 64/36 39/61 75/25
Hospital days 21.9± 1.7 22.2±2.8 25.2±3.4 19.3±2.4
ICU days 14.0± 1.7 11.5± 1.7 15.8±3.1 10.2± 1.6*
Ventilator days 6.5± 1.3 4.6± 1.4 9.4±3.4 2.3±0.5*
Intraoperative death 0 0 1 0
Postoperative deaths, No. (%) 17 (38%) 7 (23%) 10 (33%) 1 (4%)t

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