NCT03160729

Brief Summary

The aim of this study is to investigate the effect of a single preoperative high-dose steroid injection on complications in the immediate postoperative phase after open kidney surgery (kidney resection, heminephrectomy, nephrectomy). Primary outcome is complications in the post anaesthesia care unit (PACU). Secondary outcomes are organospecific complications in the post anaesthesia phase, pain and nausea the first 5 days, seroma and wound infection the first 14 days and readmissions the first 30 days after surgery. The investigators hypothesize that the frequency of transfer to the PACU and organospecific complications will be lower among patients receiving high dose dexamethasone. The investigators hypothesize, that there will be no difference in wound infections, seroma or readmissions.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2018

Completed
Last Updated

January 28, 2019

Status Verified

January 1, 2019

Enrollment Period

1.6 years

First QC Date

May 17, 2017

Last Update Submit

January 24, 2019

Conditions

Kidney DiseasesPostoperative Complications

Outcome Measures

Primary Outcomes (1)

  • Post-operative complications

    Complications requiring treatment in the PACU

    24 hours

Secondary Outcomes (13)

  • Length of stay, PACU

    24 hours

  • Length of stay, hospital

    1 month

  • Discharge score

    1 hour

  • Discharge score

    24 hours

  • Complications

    24 hours

  • +8 more secondary outcomes

Study Arms (2)

High dose

ACTIVE COMPARATOR

Dexamethasone 24 mg

Drug: Dexamethasone

Low dose

ACTIVE COMPARATOR

Dexamethasone 8 mg

Drug: Dexamethasone

Interventions

DexamethasoneDRUG

pre-operative, single-shot injection

High doseLow dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Planned open kidney resection, heminephrectomy, nephrectomy Signed informed consent

You may not qualify if:

  • chronic/ongoing use of glucocorticoids (except inhalation therapy)
  • ongoing use of immunosuppressive therapy
  • insulin dependent diabetes
  • pregnancy/breastfeeding
  • allergies toward study medication, or medication in a standard treatment
  • previous kidney resection on same side
  • thrombectomy in vena cava above diaphragma
  • surgery cannot be performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Kidney DiseasesPostoperative Complications

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Kristin J Steinthorsdottir, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, clinical assistant

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 19, 2017

Study Start

April 24, 2017

Primary Completion

November 23, 2018

Study Completion

November 23, 2018

Last Updated

January 28, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)