Enhanced Recovery After Surgery for SPK Transplantation Recipients

NCT06095544 | Completed DMC

• 1 other identifier: 2020-hs-67
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Transplant Complication; Diabetic Nephropathy; Perioperative/Postoperative Complications

Keywords

enhanced recovery after surgery, SPK transplantation

Outcome Measures

Primary Outcomes (2)

• 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).

• 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 Outcomes (1)

• 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.

Study Arms (2)

ERAS group

EXPERIMENTAL

ERAS group was consisted of evidenced-based systematic optimization approaches

Procedure: Enhanced recovery for SPK recipients

Traditional group

NO INTERVENTION

The control group received routine care

Interventions

Enhanced recovery for SPK recipients PROCEDURE

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

ERAS group

Eligibility Criteria

• Age: 20 Years - 62 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• History of allergy to narcotic drugs
• cardiopulmonary insufficiency
• congestive heart failure
• myasthenia gravis
• neurological disease
• mental illness
• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

Second affiliated hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Postoperative Complications

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective randomized controlled tiral

Study Record Dates

• First Submitted: September 16, 2023
• First Posted: October 23, 2023
• Study Start: January 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)