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Enhanced Recovery After Surgery for SPK Transplantation Recipients

A Clinical Study on the Application of Enhanced Recovery After Surgery for Simultaneous Pancreas-kidney Transplantation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06095544
Enrollment
90
Registered
2023-10-23
Start date
2021-01-01
Completion date
2023-06-01
Last updated
2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy, Perioperative/Postoperative Complications, Transplant Complication

Keywords

enhanced recovery after surgery, SPK transplantation

Brief 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.

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.

Interventions

PROCEDUREEnhanced recovery for SPK recipients

Pre-operative, perioperative and post-operative were consisted of evidenced-based systematic optimization approaches.

Sponsors

Second Affiliated Hospital of Guangzhou Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

prospective randomized controlled tiral

Eligibility

Sex/Gender
ALL
Age
20 Years to 62 Years
Healthy volunteers
Yes

Inclusion criteria

1. Patients were aged 20-62 years 2. Body mass index (BMI) of 18.5-32.9 kg/m2 3. Voluntary participation for elective SPK surgery 4. ERSD and DN patients waiting for SPK transplantation surgery.

Exclusion criteria

1. History of allergy to narcotic drugs 2. cardiopulmonary insufficiency 3. congestive heart failure 4. myasthenia gravis 5. neurological disease 6. mental illness 7. severe liver dysfunction 8. hyperkalaemia 9. malignant hyperthermia 10. unwilling to participate in the study for any reason, or had participated in another study within the 3 months

Design outcomes

Primary

MeasureTime frameDescription
Hospital costs (US dollar)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.
Length of hospital stay (LoS)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)

Secondary

MeasureTime frameDescription
Perioperative complicationsAfter 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.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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026