Preoperative High Dose Steroids for Liver Resection- Effect on Complications in the Immediate Postoperative Period (STEREO)
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|ClinicalTrials.gov Identifier: NCT03403517|
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : March 12, 2020
Several randomized clinical trials have shown beneficial effects of pre-operative glucocorticoids on post-operative complications.
Studies on the effects of glucocorticoids on the postoperative recovery after liver-resection show significantly lower markers of infection and liver damage, and some studies have shown a shorter hospital stay.
Studies on the effects in the immediate postoperative phase are lacking.
Methods: Randomized, double-blind, controlled trial evaluating incidence of postoperative complications in the immediate postoperative phase (and during admission) after open liver surgery. Participants are randomized to either active treatment (methylprednisolone 10 mg/kg) or control (8 mg dexamethasone), administered just prior to surgery.
All patients undergoing open liver resection at our institution are eligible. Included patients are stratified according to extent of surgery into minor (<3 segments) or major (≥3 segments) group.
Patients in major group participate in Substudy I (markers of endothelial damage).
Patients operated between January and July 2018 participate in Substudy II (delirium).
|Condition or disease||Intervention/treatment||Phase|
|Complication, Postoperative||Drug: Methylprednisolone Drug: Dexamethasone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||174 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||High Dose Steroids for Liver Resection - Effect on Complications and Endothelial Function in the Immediate Postoperative Phase - a Randomized, Doubleblind, Controlled Trial|
|Actual Study Start Date :||December 11, 2017|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||January 1, 2021|
10 mg/kg, single preoperative infusion
10 mg/kg methylprednisolone mixed in 100 ml NaCl (sodium chloride), infusion over 30 minutes, prior to surgery
Other Name: solu-medrol
Active Comparator: Dexamethasone
8 mg dexamethasone, single preoperative infusion
Dexamethasone mixed in 100 ml NaCl, infusion over 30 minutes, prior to surgery
- Complications, post-anesthesia care unit (PACU) [ Time Frame: up to 24 hours ]Number of patients with any complication at any time, during stay in the PACU. Complications according to DASAIMS discharge criteria (modified Aldrete criteria)
- Substudy I: Markers of endothelial dysfunction [ Time Frame: post-operative days 0 to 3 ]Amount of endothelial markers (Syndecan-1, soluble thrombomodulin, SE-Selectin, vascular endothelial growth factor (VEGF) )
- Substudy II: Delirium [ Time Frame: 5 days ]Number of patients with post-operative cognitive impairment, according to 3-minute diagnostic confusion assessment method (3D-CAM)
- Mortality [ Time Frame: 30 days ]any cause mortality
- Total complication rate [ Time Frame: 30 days ]any complications
- Hospital stay [ Time Frame: 3 months ]from operation to discharge
- PACU stay [ Time Frame: up to 24 hours ]from operation to discharge from PACU
- Pain at movement [ Time Frame: up to 24 hours ]every 60 minutes, during stay in PACU. Numeric Rating Scale (NRS 0-10)
- Pain, abdominal (postoperative) [ Time Frame: up to five days ]During admission, self reported. Numeric Rating Scale (NRS 0-10)
- Nausea [ Time Frame: up to five days ]During admission, self reported. (Light, none, moderate, heavy nausea)
- analgesic requirements [ Time Frame: up to five days ]All analgesics other than standard medication, during admission. From Medical record.
- antiemetic requirements [ Time Frame: up to five days ]All antiemetics other than standard medication, during admission. From Medical record.
- ALAT [ Time Frame: up to five days ]impact on ALAT (alanin-aminotransferase) post surgery
- Bilirubin [ Time Frame: up to five days ]impact on bilirubin post surgery
- INR [ Time Frame: up to five days ]impact on INR (International Normalized Ratio) post surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403517
|Contact: kristin email@example.com|
|Copenhagen, Denmark, 2100|
|Contact: kristin J steinthorsdottir, MD 004535451003 firstname.lastname@example.org|
|Contact: Eske K Aasvang, Dr.med 004535450802|