Transplant ComplicationNCT06095544
Enhanced Recovery After Surgery for SPK Transplantation Recipients
A study testing Enhanced recovery for SPK recipients in people with Transplant Complication and Diabetic Nephropathy, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
108 patients underwent elective SPK surgery were randomly divided into ERAS group (E) and routine care group (T). The ERAS group was consisted of evidenced-based systematic optimization approaches, while the control group received routine care. Read more about this study
- Who is it for?
- Ages 20 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Transplant Complication, Diabetic Nephropathy, Perioperative/Postoperative Complications
- What is being tested?
- Enhanced recovery for SPK recipients
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Jun 2023
- Phase
- Interventional
- 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 20 to 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients were aged 20-62 years
- Body mass index (BMI) of 18.5-32.9 kg/m2
- Voluntary participation for elective SPK surgery
- ERSD and DN patients waiting for SPK transplantation surgery.
Who cannot join
- History of allergy to narcotic drugs
- cardiopulmonary insufficiency
- congestive heart failure
- myasthenia gravis
- neurological disease
- mental illness
Show all 10Show fewer
- severe liver dysfunction
- hyperkalaemia
- malignant hyperthermia
- unwilling to participate in the study for any reason, or had participated in another study within the 3 months
Trial locations and contacts
1 site in 1 country.
China1 site
Second affiliated hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
About this study
Official title: A Clinical Study on the Application of Enhanced Recovery After Surgery for Simultaneous Pancreas-kidney Transplantation
108 patients underwent elective SPK surgery were randomly divided into ERAS group (E) and routine care group (T). The ERAS group was consisted of evidenced-based systematic optimization approaches, while the control group received routine care.
Read the detailed description
Primary results: the postoperative length of stay (LoS) and hospitalization costs; second results: post-operative analgesia score (NRS) , the incidence of post-operative nausea and vomiting (PONV) , urinary catheter removal time by 7 days , post-operative gastric tube indwelling time, the incidence of ambulation within 6 days . the dosage of dobutamine using , the dosage of norepinephrine using, and the total amount of fluid and urine volume . MAP and lactate level . Peak systolic velocity (PSV) and (resistance index) RI of grafts were checked between two groups.
- Being tested
- Enhanced recovery for SPK recipients
- Keywords
- enhanced recovery after surgery, SPK transplantation
- Medical subject headings
- Diabetic Nephropathies, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced recovery for SPK recipientsProcedure or surgery
Pre-operative, perioperative and post-operative were consisted of evidenced-based systematic optimization approaches.
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Experimental | ERAS group was consisted of evidenced-based systematic optimization approaches Receives: Procedure: Enhanced recovery for SPK recipients |
| Traditional group | No intervention | The control group received routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay (LoS)
Record the time for SPK recipients of LoS (days)
Measured: Record all the period time from the day of admiting to hospital to the day of discharge from hospital(days).
Hospital costs (US dollar)
The total cost of treatment for the patients.
Measured: Total costs(dollar) of the patients spended from the day of admiting to hospital to the day of discharge from hospital(days).
Secondary outcomes (1)
Perioperative complications
48 hours post-operative analgesia score (NRS), the incidence of post-operative nausea and vomiting (PONV) , urinary catheter removal time by 7 days , post-operative gastric tube indwelling time, the incidence of ambulation within 6 days
Measured: After the surgery acomplishment(see detail above)：record the NRS within 40hours after the surgery, occurrence rate of the PPCs within 2 weeks after the surgery, ocurrence rate of the ambulation within 6 days after the surgery, etc.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Jan 2021
- Primary completion1 Dec 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant ComplicationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Guangzhou Medical UniversityThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized controlled tiral
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095544
- Sponsor's protocol ID
- 2020-hs-67
- Status last verified
- Oct 2023
- First submitted
- 16 Sep 2023
- Last updated
- 23 Oct 2023
- 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 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Application of Enhanced Recovery After Surgery for Simultaneous Pancreas-kidney Transplantation
- ClinicalTrials.gov ID
- NCT06095544
- Acronym / sponsor ID
- 2020-hs-67
- Keywords
- enhanced recovery after surgery, SPK transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 23 Oct 2023 (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.
108 patients underwent elective SPK surgery were randomly divided into ERAS group (E) and routine care group (T). The ERAS group was consisted of evidenced-based systematic optimization approaches, while the control group received routine care.
Detailed description
Primary results: the postoperative length of stay (LoS) and hospitalization costs; second results: post-operative analgesia score (NRS) , the incidence of post-operative nausea and vomiting (PONV) , urinary catheter removal time by 7 days , post-operative gastric tube indwelling time, the incidence of ambulation within 6 days . the dosage of dobutamine using , the dosage of norepinephrine using, and the total amount of fluid and urine volume . MAP and lactate level . Peak systolic velocity (PSV) and (resistance index) RI of grafts were checked between two groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective randomized controlled tiral
| Arm | Type | Receives |
|---|---|---|
| ERAS group | Experimental | Procedure: Enhanced recovery for SPK recipientsERAS group was consisted of evidenced-based systematic optimization approaches |
| Traditional group | No intervention | –The control group received routine care |
Who may qualify
- Ages
- 20 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients were aged 20-62 years
- Body mass index (BMI) of 18.5-32.9 kg/m2
- Voluntary participation for elective SPK surgery
- ERSD and DN patients waiting for SPK transplantation surgery.
Key exclusion criteria (10 listed)
- History of allergy to narcotic drugs
- cardiopulmonary insufficiency
- congestive heart failure
- myasthenia gravis
- neurological disease
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 |
|---|---|---|
| Enhanced recovery for SPK recipientsPre-operative, perioperative and post-operative were consisted of evidenced-based systematic optimization approaches. | Procedure or surgery | ERAS group |
Primary outcome
Length of hospital stay (LoS)
Time frame: Record all the period time from the day of admiting to hospital to the day of discharge from hospital(days).
Record the time for SPK recipients of LoS (days)
Hospital costs (US dollar)
Time frame: Total costs(dollar) of the patients spended from the day of admiting to hospital to the day of discharge from hospital(days).
The total cost of treatment for the patients.
1 secondary outcome
Perioperative complications
Time frame: After the surgery acomplishment(see detail above)：record the NRS within 40hours after the surgery, occurrence rate of the PPCs within 2 weeks after the surgery, ocurrence rate of the ambulation within 6 days after the surgery, etc.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced recovery for SPK recipients in people with Transplant Complication and Diabetic Nephropathy, run by Second Affiliated Hospital of Guangzhou Medical University 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 23 Oct 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Length of hospital stay (LoS) (time frame: Record all the period time from the day of admiting to hospital to the day of discharge from hospital(days).). The study lists 2 primary outcomes in all. 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 23 Oct 2023.