Enhanced Recovery After Surgery for SPK Transplantation Recipients

Not Applicable

Completed

• Conditions: Transplant Complication; Diabetic Nephropathy; Perioperative/Postoperative Complications
• Interventions: Procedure: Enhanced recovery for SPK recipients

• Registration Number: NCT06095544
• Lead Sponsor: Second Affiliated Hospital of Guangzhou Medical University

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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-06-01
• Study First Submitted: 2023-09-16
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-18
• Last Update Submitted: 2023-10-18
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERAS group	Enhanced recovery for SPK recipients	ERAS group was consisted of evidenced-based systematic optimization approaches

Primary Outcome Measures

Name	Time	Method
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)
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.

Secondary Outcome Measures

Name	Time	Method
Perioperative complications	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.	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

Trial Locations

Locations (1)

Second affiliated hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China