Kidney DiseasesPhase 4DEX-NEFNCT03160729
High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Nephrectomy
A Phase 4 study testing Dexamethasone in people with Kidney Diseases and Postoperative Complications, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases, Postoperative Complications
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Apr 2017to 23 Nov 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned open kidney resection, heminephrectomy, nephrectomy Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Nephrectomy (DEX-NEF)
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.
Read the detailed description
Post-surgery, patients are traditionally observed and treated in post-anesthesia care units (PACU) until they are discharged to the ward (or directly home) assessed by standardized international discharge criteria.
The research project "Why in PACU?" (Rigshospitalet, Denmark), has since the beginning of 2016 systematically collected and analyzed procedure-related complications in the recovery phase. The complications include pain, nausea/vomiting, circulatory and respiratory problems, orthostatic intolerance and cognitive disorders. Common to all the above-mentioned post-operative problems are the possible links to the inflammatory response caused by the surgical trauma.
Glucocorticoids can in this context be central for the reduction of acute postoperative organ dysfunctions, caused by the anti-inflammatory effect. In a number of different surgical procedures, single dose, pre-operative glucocorticoids have been shown to reduce post-operative nausea and vomiting (PONV), acute pain and need of opioids as well as accelerate the convalescence.
Meta-analyses also showed that single-dose administration of glucocorticoids (methylprednisolone and dexamethasone) for surgical patients is safe as opposed to long-term treatment.
The "Why in PACU?" database shows that 60 % of patients having open kidney surgery have complications in the PACU (primarily pain and hypoxia).
Based on positive results in other procedure-specific studies, all donor-nephrectomy patients at Rigshospitalet, have received pre-operative high-dose steroids, in the form of 24 mg dexamethasone injection since mid-2015. This has resulted in a reduction of pain requiring treatment with 30 %.
Prior to creating clinical recommendations and standards, it is required that the results be tested in a randomized, controlled, clinical trial.
The study is not placebo-controlled since the positive effects of dexamethasone 8 mg on PONV have been shown in numerous trials, and is already being administered to all patients at the clinic. It would therefore not be ethically correct to withdraw from this practise
- Conditions
- Kidney Diseases, Postoperative Complications
- Being tested
- Dexamethasone
- Medical subject headings
- Kidney Diseases, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
pre-operative, single-shot injection
| Study group | Role | What they receive |
|---|---|---|
| High dose | Active comparator | Dexamethasone 24 mg Receives: Drug: Dexamethasone |
| Low dose | Active comparator | Dexamethasone 8 mg Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative complications
Complications requiring treatment in the PACU
Measured: 24 hours
Secondary outcomes (13)
Length of stay, PACU
Total length of stay in PACU
Measured: 24 hours
Length of stay, hospital
Total length of stay in hospital
Measured: 1 month
Discharge score
Discharge score (according to discharge criteria) in the operating theater
Measured: 1 hour
Discharge score
Discharge score (according to discharge criteria) in the PACU
Measured: 24 hours
Complications
Complications requiring treatment in the ward
Measured: 24 hours
Pain postoperative
Self-reported pain (worst and average, days 0-4). Questionnaire.
Measured: 4 days
Analgesics
Self-reported use of pain medication other than standard treatment (days 0-4). Questionnaire.
Measured: 4 days
Post operative nausea and vomiting (PONV)
Self-reported ponv (worst and average, days 0-4. Questionnaire.
Measured: 4 days
Antiemetics
Use of antiemetics other than standard treatment (days 0-4. Questionnaire.
Measured: 4 days
Sleep
Self-reported quality of sleep (days 0-4). Questionnaire.
Measured: 4 days
Mental status
Self-reported feelings of anxiety, unrest, sadness (days 0-4). Questionnaire.
Measured: 4 days
Wound complications
Wound complications/infections
Measured: 30 days
Readmissions
Any readmissions
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start24 Apr 2017
- Primary completion23 Nov 2018
- Study completion23 Nov 2018
Why it stopped: Slow recruitment, schanges in standard treatment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Julia Steinthorsdottir, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kristin J Steinthorsdottir, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160729
- Sponsor's protocol ID
- DEXNEF01
- Acronym
- DEX-NEF
- Status last verified
- Jan 2019
- First submitted
- 17 May 2017
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Nephrectomy (DEX-NEF)
- ClinicalTrials.gov ID
- NCT03160729
- Acronym / sponsor ID
- DEX-NEF / DEXNEF01
- Conditions
- Kidney Diseases, Postoperative Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment, schanges in standard treatment
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 23 Nov 2018 (actual)
- Study completion
- 23 Nov 2018 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Post-surgery, patients are traditionally observed and treated in post-anesthesia care units (PACU) until they are discharged to the ward (or directly home) assessed by standardized international discharge criteria.
The research project "Why in PACU?" (Rigshospitalet, Denmark), has since the beginning of 2016 systematically collected and analyzed procedure-related complications in the recovery phase. The complications include pain, nausea/vomiting, circulatory and respiratory problems, orthostatic intolerance and cognitive disorders. Common to all the above-mentioned post-operative problems are the possible links to the inflammatory response caused by the surgical trauma.
Glucocorticoids can in this context be central for the reduction of acute postoperative organ dysfunctions, caused by the anti-inflammatory effect. In a number of different surgical procedures, single dose, pre-operative glucocorticoids have been shown to reduce post-operative nausea and vomiting (PONV), acute pain and need of opioids as well as accelerate the convalescence.
Meta-analyses also showed that single-dose administration of glucocorticoids (methylprednisolone and dexamethasone) for surgical patients is safe as opposed to long-term treatment.
The "Why in PACU?" database shows that 60 % of patients having open kidney surgery have complications in the PACU (primarily pain and hypoxia).
Based on positive results in other procedure-specific studies, all donor-nephrectomy patients at Rigshospitalet, have received pre-operative high-dose steroids, in the form of 24 mg dexamethasone injection since mid-2015. This has resulted in a reduction of pain requiring treatment with 30 %.
Prior to creating clinical recommendations and standards, it is required that the results be tested in a randomized, controlled, clinical trial.
The study is not placebo-controlled since the positive effects of dexamethasone 8 mg on PONV have been shown in numerous trials, and is already being administered to all patients at the clinic. It would therefore not be ethically correct to withdraw from this practise
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose | Active comparator | Drug: DexamethasoneDexamethasone 24 mg |
| Low dose | Active comparator | Drug: DexamethasoneDexamethasone 8 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Planned open kidney resection, heminephrectomy, nephrectomy Signed informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasonepre-operative, single-shot injection | Drug | High dose, Low dose |
Primary outcome
Post-operative complications
Time frame: 24 hours
Complications requiring treatment in the PACU
13 secondary outcomes
Length of stay, PACU
Time frame: 24 hours
Length of stay, hospital
Time frame: 1 month
Discharge score
Time frame: 1 hour
Discharge score
Time frame: 24 hours
Complications
Time frame: 24 hours
Pain postoperative
Time frame: 4 days
Analgesics
Time frame: 4 days
Post operative nausea and vomiting (PONV)
Time frame: 4 days
Antiemetics
Time frame: 4 days
Sleep
Time frame: 4 days
Mental status
Time frame: 4 days
Wound complications
Time frame: 30 days
Readmissions
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Slow recruitment, schanges in standard treatment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin J Steinthorsdottir, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Kidney Diseases and Postoperative Complications, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment, schanges in standard treatment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative complications (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2019.