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Enhanced Recovery After Surgery for SPK Transplantation Recipients

Primary Purpose

Transplant Complication, Diabetic Nephropathy, Perioperative/Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Enhanced recovery for SPK recipients
Sponsored by
Second Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Transplant Complication focused on measuring enhanced recovery after surgery, SPK transplantation

Eligibility Criteria

20 Years - 62 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Second affiliated hospital of Guangzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ERAS group

Traditional group

Arm Description

ERAS group was consisted of evidenced-based systematic optimization approaches

The control group received routine care

Outcomes

Primary Outcome Measures

Length of hospital stay (LoS)
Record the time for SPK recipients of LoS (days)
Hospital costs (US dollar)
The total cost of treatment for the patients.

Secondary Outcome Measures

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

Full Information

First Posted
September 16, 2023
Last Updated
October 18, 2023
Sponsor
Second Affiliated Hospital of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT06095544
Brief Title
Enhanced Recovery After Surgery for SPK Transplantation Recipients
Official Title
A Clinical Study on the Application of Enhanced Recovery After Surgery for Simultaneous Pancreas-kidney Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transplant Complication, Diabetic Nephropathy, Perioperative/Postoperative Complications
Keywords
enhanced recovery after surgery, SPK transplantation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized controlled tiral
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ERAS group
Arm Type
Experimental
Arm Description
ERAS group was consisted of evidenced-based systematic optimization approaches
Arm Title
Traditional group
Arm Type
No Intervention
Arm Description
The control group received routine care
Intervention Type
Procedure
Intervention Name(s)
Enhanced recovery for SPK recipients
Intervention Description
Pre-operative, perioperative and post-operative were consisted of evidenced-based systematic optimization approaches.
Primary Outcome Measure Information:
Title
Length of hospital stay (LoS)
Description
Record the time for SPK recipients of LoS (days)
Time Frame
Record all the period time from the day of admiting to hospital to the day of discharge from hospital(days).
Title
Hospital costs (US dollar)
Description
The total cost of treatment for the patients.
Time Frame
Total costs(dollar) of the patients spended from the day of admiting to hospital to the day of discharge from hospital(days).
Secondary Outcome Measure Information:
Title
Perioperative complications
Description
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
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Second affiliated hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Enhanced Recovery After Surgery for SPK Transplantation Recipients

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