Enhanced Recovery After Surgery for SPK Transplantation Recipients

Diabetic Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06095544
• Other study ID #: 2020-hs-67
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: October 2023
• Source: Second Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 62 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Procedure:
• Enhanced recovery for SPK recipients
Pre-operative, perioperative and post-operative were consisted of evidenced-based systematic optimization approaches.

Locations

Country	Name	City	State
China	Second affiliated hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay (LoS)	Record the time for SPK recipients of LoS (days)	Record all the period time from the day of admiting to hospital to the day of discharge from hospital(days).
Primary	Hospital costs (US dollar)	The total cost of treatment for the patients.	Total costs(dollar) of the patients spended from the day of admiting to hospital to the day of discharge from hospital(days).
Secondary	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	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.