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. 2017 Jan 18;2017(1):CD010959. doi: 10.1002/14651858.CD010959.pub2

Schroeder 2009.

Methods Study design: parallel‐group, open‐label, randomized controlled trial
Setting: ICU of the Department of Anesthesiology and Intensive Care Medicine at Westküstenklinikum Heide (Germany)
Participants Inclusion criteria: patients after abdominal surgery and after the start of antibiotic treatment with the diagnosis of severe sepsis (according to ACCP/SCCM Consensus Conference Committee 1992 criteria)
Exclusion criteria: patients who did not meet the inclusion criteria, who refused informed consent or who already had received antibiotic treatment before admission to the ICU
Interventions Group 1 (n = 14): Antibiotic therapy was discontinued if clinical signs and symptoms of sepsis improved and PCT values decreased to 1 ng/mL or less or dropped to 25% to 35% of the initial PCT concentration over 3 consecutive days, but the physician in charge was always free to decide whether to continue or change the antibiotic regimen upon clinical judgement. Daily standard routine laboratory analysis including C‐reactive protein (CRP) was performed. Participants were also subjected to daily standard routine laboratory analysis, including CRP.
Group 2 (n = 13): Antibiotic treatment was discontinued according to clinical signs and empirical rules, but the physician in charge was always free to decide whether to continue or change the antibiotic regimen upon clinical judgement. Participants were also subjected to daily standard routine laboratory analysis, including CRP, in the same way as those in the PCT group.
Outcomes

  1. Length of hospital stay

  2. Length of intensive care unit (ICU) stay (days)

  3. Duration of antibiotic treatment (days)

  4. PCT concentration

  5. C‐reactive protein (CRP) levels

  6. Participants receiving the following antibiotic substances: acylaminopenicillin + beta lactamase inhibitor; acylaminopenicillin + nitroimidazole and carbapenem

  7. SOFAmax, defined as the "highest Sequential Organ Failure Assessment Score during the study period"

  8. Mortality until hospital discharge
Conflicts of interest and/or funding The corresponding author declared speaking engagements for BRAHMS AG.
Notes Sample size: Duration of antibiotic therapy for participants treated with a PCT‐guided protocol would be at least 25% shorter than the duration observed in participants treated according to a protocol based on serum CRP levels, resulting in 58 participants per group ‐ totalling 116 individuals (power of 80% and alpha error of 5%).
PCT measures: BRAHMS PCT LIA® ‐ B.R.A.H.M.S. Aktiengesellschaft, Hennigsdorf (Germany)
We had no success in contacting study authors.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not informed
Allocation concealment (selection bias) Unclear risk Not informed
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not informed
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not informed
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Study authors made available a clear flow of participants within the study (all participants were analysed).
Selective reporting (reporting bias) Low risk Relevant outcomes were evaluated.
Other bias Low risk None was suspected.
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