Postoperative Delirium After Living Donor Renal TransplantationPhase 4NCT02509949
Effects of Dexmedetomidine on Delirium After Living Donor Renal Transplantation in Adult Patients
A Phase 4 study testing Dexmedetomidine and Saline in people with Postoperative Delirium After Living Donor Renal Transplantation, run by Tao Zhang at 1 site in China.
Trial summary
Delirium, an acute change in mental status, is a serious medical complication among hospitalized patients. Syndrome of delirium involves agitation, sleep disturbance, affective disorders and cognitive disruptions. One vulnerable period for developing delirium is in the postoperative days. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Postoperative Delirium After Living Donor Renal Transplantation
- What is being tested?
- Dexmedetomidine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Sep 2019
- 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 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age > 17 and < 60 years;
- American Society of Anesthesiology (ASA) I-III;
- admitted for living donor renal transplantation.
Who cannot join
- Patients with a history of drug abuse;
- preoperative history of schizophrenia, epilepsy, parkinsonism, use of cholinesterase inhibitor, inability to communicate in the preoperative period (coma, profound dementia, or language barrier).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Tao Zhang, Master of Medicine, 13580482938, zhtao98@aliyun.com
About this study
Delirium, an acute change in mental status, is a serious medical complication among hospitalized patients. Syndrome of delirium involves agitation, sleep disturbance, affective disorders and cognitive disruptions.
One vulnerable period for developing delirium is in the postoperative days. Postoperative delirium often initiates a cascade of adverse consequences including an increase in length of stay and hospital costs, and greater mortality. The investigators have observed that the incidence of postoperative delirium in patients after renal transplantation is about 20-30% in our hospital.
Several studies have revealed that dexmedetomidine, as a widely used sedative during anesthesia, can decrease the incidence of postoperative delirium after cardiac surgery. The investigators aim to examine whether administration of dexmedetomidine can reduce postoperative delirium after living donor renal transplantation in adult patients.
- Being tested
- Dexmedetomidine, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Dexmedetomidine ivpump 0.2ug/kg/h during living donor renal transplantation. Receives: Drug: Dexmedetomidine |
| Saline | Placebo comparator | Saline ivpump 0.2ug/kg/h during living donor renal transplantation. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Delirium
Measured: Postoperative day 1-7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Delirium After Living Donor Renal TransplantationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tao Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tao Zhang, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509949
- Sponsor's protocol ID
- DDRT
- Status last verified
- Jun 2018
- First submitted
- 24 Jul 2015
- Last updated
- 12 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine on Delirium After Living Donor Renal Transplantation in Adult Patients
- ClinicalTrials.gov ID
- NCT02509949
- Acronym / sponsor ID
- DDRT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tao ZhangUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Sep 2019 (estimated)
- First posted
- 28 Jul 2015 (estimated)
- 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.
Delirium, an acute change in mental status, is a serious medical complication among hospitalized patients. Syndrome of delirium involves agitation, sleep disturbance, affective disorders and cognitive disruptions.
One vulnerable period for developing delirium is in the postoperative days. Postoperative delirium often initiates a cascade of adverse consequences including an increase in length of stay and hospital costs, and greater mortality. The investigators have observed that the incidence of postoperative delirium in patients after renal transplantation is about 20-30% in our hospital.
Several studies have revealed that dexmedetomidine, as a widely used sedative during anesthesia, can decrease the incidence of postoperative delirium after cardiac surgery. The investigators aim to examine whether administration of dexmedetomidine can reduce postoperative delirium after living donor renal transplantation in adult patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidineDexmedetomidine ivpump 0.2ug/kg/h during living donor renal transplantation. |
| Saline | Placebo comparator | Drug: SalineSaline ivpump 0.2ug/kg/h during living donor renal transplantation. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age > 17 and < 60 years;
- American Society of Anesthesiology (ASA) I-III;
- admitted for living donor renal transplantation.
Key exclusion criteria (2 listed)
- Patients with a history of drug abuse;
- preoperative history of schizophrenia, epilepsy, parkinsonism, use of cholinesterase inhibitor, inability to communicate in the preoperative period (coma, profound dementia, or language barrier).
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 |
|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine |
| Saline | Drug | Saline |
Primary outcome
Postoperative Delirium
Time frame: Postoperative day 1-7.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
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.
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 Dexmedetomidine and Saline in people with Postoperative Delirium After Living Donor Renal Transplantation, run by Tao Zhang at 1 site in China.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Jun 2018. 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Delirium (time frame: Postoperative day 1-7.). 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 12 Jun 2018.