Enhanced Recovery After Surgery for SPK Transplantation Recipients

Sponsor

Second Affiliated Hospital of Guangzhou Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT06095544

Collaborator

(none)

Enrollment

Location

Arms

28.9

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transplant Complication Diabetic Nephropathy Perioperative/Postoperative Complications	Procedure: Enhanced recovery for SPK recipients	N/A

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

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective randomized controlled tiralprospective randomized controlled tiral

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Dec 1, 2022

Actual Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ERAS group ERAS group was consisted of evidenced-based systematic optimization approaches	Procedure: Enhanced recovery for SPK recipients Pre-operative, perioperative and post-operative were consisted of evidenced-based systematic optimization approaches.
No Intervention: Traditional group The control group received routine care

Arm

Intervention/Treatment

Experimental: ERAS group

ERAS group was consisted of evidenced-based systematic optimization approaches

Procedure: Enhanced recovery for SPK recipients

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

No Intervention: Traditional group

The control group received routine care

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 62 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second affiliated hospital of Guangzhou Medical University	Guangzhou	Guangdong	China	510260

Sponsors and Collaborators

Second Affiliated Hospital of Guangzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital of Guangzhou Medical University

ClinicalTrials.gov Identifier:

NCT06095544

Other Study ID Numbers:

2020-hs-67

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Second Affiliated Hospital of Guangzhou Medical University

enhanced recovery after surgery, SPK transplantation

Additional relevant MeSH terms:

Diabetic Nephropathies

Postoperative Complications

Study Results

No Results Posted as of Oct 23, 2023