- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02356484
Surgical Stress Markers for Postoperative Complications: a Prospective Study
Predictive Value of Surgical Stress Markers for Postoperative Complications: a Prospective Study
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
This prospective study was conducted at the Department for Visceral Surgery at the University Hospital of Lausanne Switzerland (CHUV) between February and December 2015 (NCT02356484). The study was approved by the Institutional Review Board (No. 367/15), and all patients provided written consent prior to surgery. Inclusion criteria were age >18 years, and elective major abdominal surgery-defined as an operative procedure with anticipated duration ≥2 hours.17 Perioperative care closely adhered to recently published enhanced recovery guidelines (http://erassociety.org.loopiadns.com/guidelines/list-of-guidelines). Standardised fluid administration was followed by advanced haemodynamic monitoring to avoid intraoperative fluid overload. According to the clinical care pathway, intravenous fluid was typically discontinued the morning after surgery.
Biological markers Serum levels of albumin, CRP, PCT and lactate (LCT) were perioperatively measured in a fasting state, Following standardised institutional guidelines. Blood samples were drawn the day before surgery, the day of surgery (4-6 hours after the end of the operation) and on the first, second and third postoperative day. As Baseline values tend to show large variations especially for albumin,4 10 we considered that a dynamic value (difference between two time-points) might be more informative than a snapshot value. Several values based on preoperative and postoperative concentrations were thus calculated for each marker (ie, Δ Max: maximal difference between the preoperative and postoperative values; Δ POD 0: difference of concentration on POD -1 and POD 0; Δ POD 1: difference of concentration on POD-1 and POD 1).
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Vaud
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Lausanne, Vaud, Schweiz
- University of Lausanne Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Patients over 18 years old
- Patients undergoing esophagus, gastric, liver, pancreas, endocrine, retroperitoneal, or colorectal surgery
- Operation time more than 2 hours
- Operation including an organ resection for benign or malignant disease
Exclusion Criteria:
- Immunosuppressive therapy
- Cognitive impairment or language comprehension problems
- Absence of the consent form prior to first blood sample
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Major abdominal surgery cohort
In this surgical cohort, 4 inflammatory markers were measured: albumin, procalcitonin, CRP and lactate levels
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Predictive Value of Postoperative Albumin Decrease in Terms of Surgical Stress and Postoperative Complications
Tidsram: Albumin preoperatively (day -1) and postoperatively (day 1) after surgery
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Delta albumin (g/l) before (day -1) and immediately (day 1) after surgery as a predictor of postoperative complications (until 30 days post surgery)
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Albumin preoperatively (day -1) and postoperatively (day 1) after surgery
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Martin Hübner, MD, University of Lausanne Hospital
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 471/14
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