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)
90
1
2
28.9
3.1

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
  • 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

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. 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

  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.]

    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:
  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

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:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Second Affiliated Hospital of Guangzhou Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023