Enhanced Recovery After Surgery for SPK Transplantation Recipients

October 18, 2023 updated by: Second Affiliated Hospital of Guangzhou Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510260
        • Second Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay (LoS)
Time Frame: 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)
Record all the period time from the day of admiting to hospital to the day of discharge from hospital(days).
Hospital costs (US dollar)
Time Frame: 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.
Total costs(dollar) of the patients spended from the day of admiting to hospital to the day of discharge from hospital(days).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative complications
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

September 16, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-hs-67

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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