- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02356484
Surgical Stress Markers for Postoperative Complications: a Prospective Study
Predictive Value of Surgical Stress Markers for Postoperative Complications: a Prospective Study
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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).
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Vaud
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Lausanne, Vaud, Schweiz
- University of Lausanne Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Predictive Value of Postoperative Albumin Decrease in Terms of Surgical Stress and Postoperative Complications
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Martin Hübner, MD, University of Lausanne Hospital
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 471/14
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