Trial Outcomes & Findings for Preoperative High Dose Steroids for Liver Resection- Effect on Complications in the Immediate Postoperative Period (NCT NCT03403517)

Results Overview

Number of patients with any complication at any time, during stay in the PACU. Complications according to DASAIMS discharge criteria (modified Aldrete criteria)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

174 participants

Primary outcome timeframe

up to 24 hours

Results posted on

2021-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	Methylprednisolone 10 mg/kg, single preoperative infusion Methylprednisolone: 10 mg/kg methylprednisolone mixed in 100 ml NaCl (sodium chloride), infusion over 30 minutes, prior to surgery	Dexamethasone 8 mg dexamethasone, single preoperative infusion Dexamethasone: Dexamethasone mixed in 100 ml NaCl, infusion over 30 minutes, prior to surgery
Overall Study STARTED	88	86
Overall Study COMPLETED	88	86
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Methylprednisolone n=88 Participants 10 mg/kg, single preoperative infusion Methylprednisolone: 10 mg/kg methylprednisolone mixed in 100 ml NaCl (sodium chloride), infusion over 30 minutes, prior to surgery	Dexamethasone n=86 Participants 8 mg dexamethasone, single preoperative infusion Dexamethasone: Dexamethasone mixed in 100 ml NaCl, infusion over 30 minutes, prior to surgery	Total n=174 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 11 • n=88 Participants	64 years STANDARD_DEVIATION 12 • n=86 Participants	65 years STANDARD_DEVIATION 12 • n=174 Participants
Sex: Female, Male Female	32 Participants n=88 Participants	25 Participants n=86 Participants	57 Participants n=174 Participants
Sex: Female, Male Male	56 Participants n=88 Participants	61 Participants n=86 Participants	117 Participants n=174 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Methylprednisolone n=88 Participants 10 mg/kg, single preoperative infusion Methylprednisolone: 10 mg/kg methylprednisolone mixed in 100 ml NaCl (sodium chloride), infusion over 30 minutes, prior to surgery	Dexamethasone n=86 Participants 8 mg dexamethasone, single preoperative infusion Dexamethasone: Dexamethasone mixed in 100 ml NaCl, infusion over 30 minutes, prior to surgery
Complications, Post-anesthesia Care Unit (PACU)	51 Participants	58 Participants

PRIMARY outcome

Timeframe: post-operative days 0 to 3

Amount of endothelial markers (Syndecan-1, soluble thrombomodulin, SE-Selectin, vascular endothelial growth factor (VEGF) )

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 5 days

Number of patients with post-operative cognitive impairment, according to 3-minute diagnostic confusion assessment method (3D-CAM)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

any cause mortality

Outcome measures

Outcome measures
Measure	Methylprednisolone n=88 Participants 10 mg/kg, single preoperative infusion Methylprednisolone: 10 mg/kg methylprednisolone mixed in 100 ml NaCl (sodium chloride), infusion over 30 minutes, prior to surgery	Dexamethasone n=86 Participants 8 mg dexamethasone, single preoperative infusion Dexamethasone: Dexamethasone mixed in 100 ml NaCl, infusion over 30 minutes, prior to surgery
Mortality	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

any complications, 30 day morbidity

Outcome measures

Outcome measures
Measure	Methylprednisolone n=88 Participants 10 mg/kg, single preoperative infusion Methylprednisolone: 10 mg/kg methylprednisolone mixed in 100 ml NaCl (sodium chloride), infusion over 30 minutes, prior to surgery	Dexamethasone n=86 Participants 8 mg dexamethasone, single preoperative infusion Dexamethasone: Dexamethasone mixed in 100 ml NaCl, infusion over 30 minutes, prior to surgery
Total Complication Rate	19 Participants	19 Participants

SECONDARY outcome

Timeframe: 3 months

from operation to discharge

Outcome measures

Outcome measures
Measure	Methylprednisolone n=88 Participants 10 mg/kg, single preoperative infusion Methylprednisolone: 10 mg/kg methylprednisolone mixed in 100 ml NaCl (sodium chloride), infusion over 30 minutes, prior to surgery	Dexamethasone n=86 Participants 8 mg dexamethasone, single preoperative infusion Dexamethasone: Dexamethasone mixed in 100 ml NaCl, infusion over 30 minutes, prior to surgery
Hospital Stay	98 hours Interval 77.0 to 147.0	102 hours Interval 93.0 to 144.0

SECONDARY outcome

Timeframe: up to 24 hours

from operation to discharge from PACU

Outcome measures

Outcome measures
Measure	Methylprednisolone n=88 Participants 10 mg/kg, single preoperative infusion Methylprednisolone: 10 mg/kg methylprednisolone mixed in 100 ml NaCl (sodium chloride), infusion over 30 minutes, prior to surgery	Dexamethasone n=86 Participants 8 mg dexamethasone, single preoperative infusion Dexamethasone: Dexamethasone mixed in 100 ml NaCl, infusion over 30 minutes, prior to surgery
PACU Stay	203 minutes Interval 143.0 to 320.0	186 minutes Interval 156.0 to 225.0

SECONDARY outcome

Timeframe: up to 24 hours

every 60 minutes, during stay in PACU. Numeric Rating Scale (NRS 0-10)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to five days

During admission, self reported. Numeric Rating Scale (NRS 0-10)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to five days

During admission, self reported. (Light, none, moderate, heavy nausea)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to five days

All analgesics other than standard medication, during admission. From Medical record.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to five days

All antiemetics other than standard medication, during admission. From Medical record.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to five days

impact on ALAT (alanin-aminotransferase) post surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to five days

impact on bilirubin post surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to five days

impact on INR (International Normalized Ratio) post surgery

Outcome measures

Outcome data not reported

Adverse Events

Methylprednisolone

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexamethasone

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Methylprednisolone n=88 participants at risk 10 mg/kg, single preoperative infusion Methylprednisolone: 10 mg/kg methylprednisolone mixed in 100 ml NaCl (sodium chloride), infusion over 30 minutes, prior to surgery	Dexamethasone n=86 participants at risk 8 mg dexamethasone, single preoperative infusion Dexamethasone: Dexamethasone mixed in 100 ml NaCl, infusion over 30 minutes, prior to surgery
Hepatobiliary disorders variceal bleeding	0.00% 0/88 • 40 hours after drug administration According to GCP definitions	1.2% 1/86 • Number of events 2 • 40 hours after drug administration According to GCP definitions
Hepatobiliary disorders bile lesion	2.3% 2/88 • Number of events 2 • 40 hours after drug administration According to GCP definitions	0.00% 0/86 • 40 hours after drug administration According to GCP definitions

Other adverse events

Adverse event data not reported

Additional Information

Kristin steinthorsdottir

Rigshospitalet

Phone: 004531666112

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place