A Randomized Trial of Protocol-Based Care for Early Septic Shock
2014 · paper · Clinical trials
A trial in 31 US emergency departments comparing protocol-based early goal-directed therapy, protocol-based standard therapy, and usual care for 1,341 patients with septic shock. Death by 60 days was similar across groups (21.0%, 18.2%, 18.9%), so protocol-based care did not improve outcomes.
0 findings
None that passed a second check.
10 minor (typos and the like; most checked by the judge only)
Wording Abstract states "There were no significant differences in 90-day mortality, 1-year mortality, or the need for organ support", but Table 2 shows new renal failure (defined in Results as "a new need for renal-replacement therapy") differed across groups: 12/382 (3.1), 24/399 (6.0), 11/397 (2.8), P = 0.04.
- p. 1 Abstract, Results
There were no significant differences in 90-day mortality, 1-year mortality, or the need for organ support.
- p. 16 Table 2, New organ failure in the first week, Renal
24/399 (6.0)
- p. 8 Discussion, paragraph 1
a higher requirement for intensive care and renal-replacement therapy
Only the authors can say what is right here.
Judge's note: Checked abstract (p1), Table 2 (p16) and Results p7 lines defining renal failure as new need for renal-replacement therapy (P = 0.04); Discussion (p8) itself reports a higher requirement for renal-replacement therapy. Methods set P<0.05 as significant. The abstract may mean duration of organ support or cardiovascular/respiratory support only, but it doesn't say so. Authors should clarify.
Second check: another model agreed
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Wording Discussion: "The two protocol-based resuscitation approaches led to ... a higher requirement for intensive care and renal-replacement therapy". The Results attribute higher ICU admission only to EGDT (91.3% vs 85.4% and 86.2%) and higher RRT only to standard therapy (6.0% vs 3.1% and 2.8%).
- p. 8 Discussion, paragraph 1
a higher requirement for intensive care and renal-replacement therapy
- p. 7 Results, Outcomes, paragraph 2
was higher in the protocol-based standard-therapy group than in the other two groups
- p. 16 Table 2, Admission to intensive care unit row
401 (91.3)
Only the authors can say what is right here.
Judge's note: Checked the Results on p7 and Table 2 on p16. In each case the excess is in one protocol group, not both. The standard-therapy ICU rate (85.4%) is below usual care (86.2%). No pooled-group test is reported for these outcomes. The wording overstates the group-level data.
Second check: another model agreed
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Wording Table 2 serious adverse events 23 (5.2), 22 (4.9), 37 (8.1) with P = 0.32: the printed counts and P value do not correspond under the declared test (three-group Fisher's exact, footnote †).
- p. 16 Table 2, Serious adverse events row
23 (5.2)
- p. 16 Table 2, Serious adverse events row, P value column
0.32
- p. 16 Table 2 footnote †
with the use of Fisher’s exact test for categorical measures
Only the authors can say what is right here.
Judge's note: From the p16 image, my three-group chi-square approximation on 23/439, 22/446, 37/456 gives chi-square ≈ 4.85, df 2, P ≈ 0.09. The same method reproduces renal (chi-square ≈ 6.5, P ≈ 0.04, printed 0.04). Footnote ¶ points to Table S5, which is not in the files; it may show a different counting unit or test. Both 0.09 and 0.32 are above 0.05, so the stated non-significance is unaffected. Authors should confirm the test and counts.
Second check: another model agreed
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Typo "the method for screening for cryptogenic shock": the usual term for occult hypoperfusion detected by lactate is "cryptic shock".
- p. 3 Sites and Patients, first paragraph
screening for cryptogenic shock
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: the established term in sepsis literature is "cryptic shock", not "cryptogenic shock". The page image (p3) prints "cryptogenic shock"; the term appears nowhere else in the paper.
Second check: none (judge only)
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Typo Unmatched closing parenthesis: "no reason was provided in the case of 4 patients). The mean"; the list of reasons is not opened with a parenthesis.
- p. 6 Adherence to the Protocol
no reason was provided in the case of 4 patients).
Judge's note: Checked on the p6 image. The sentence starts "The reasons for failure to place a central venous catheter, which occurred in 30 of the 439 patients..." and has no opening parenthesis for this closing one. The counts add up: 10+9+5+1+1+4 = 30.
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Typo The parenthesis opened at "(2.8 liters in the protocol-based EGDT group, ... 2.3 liters in the usual-care group (P<0.001)" is never closed.
- p. 6 Resuscitation, first sentence
among the groups (2.8 liters in the protocol-based EGDT group
Judge's note: Seen on the p6 image: '(2.8 liters ... usual-care group (P<0.001) (Table S4 and Fig. S6C ...)'. The outer parenthesis lacks a closing bracket; it should read '... usual-care group; P<0.001)'.
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Typo "3.5% [16 patients] in the usual-care groups": plural used for the single usual-care group.
- p. 6 Adherence to the Protocol, last sentence
3.5% [16 patients] in the usual-care groups
- p. 6 Adherence to the Protocol
in the usual-care groups, vs. 93.6%
Judge's note: Seen on the p6 image. The trial has one usual-care group (N = 456). Percentages check out.
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Typo Reference 8 prints "Protocolized Care for Early Septic Shock (Process) statistical analysis plan", while the acronym is "ProCESS" elsewhere.
- p. 10 Reference 8
Early Septic Shock (Process) statistical
Judge's note: Seen on the p10 image. The capitalization is inconsistent with the paper's own usage (p1, p2). It may come from reference-database formatting, so this is cosmetic.
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Typo Table 1 serum lactate prints "5±3.6" beside "4.8±3.1" and "4.9±3.1" (trailing zero dropped).
- p. 14 Table 1, Serum lactate
5±3.6
Judge's note: Seen on the p14 crop. The manuscript drops trailing zeros elsewhere too (Table 2 "8.5±12", "11.1±10"), so this is a typesetting habit. It is purely cosmetic.
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Typo Table 2 row label "Discharge to another acute care hospital" is inconsistent with the neighbouring "Discharged to ..." rows.
- p. 16 Table 2, discharge status
Discharge to another acute care hospital
Judge's note: Seen on the p16 image. The other rows read "Discharged to a long-term acute care facility", "Discharged to nursing home" and "Discharged home". This is cosmetic.
Second check: none (judge only)