Enhanced Recovery After Surgery for SPK Transplantation Recipients

NCT ID: NCT06095544

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-06-01

Brief Summary

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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

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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.

Conditions

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Transplant Complication Diabetic Nephropathy Perioperative/Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective randomized controlled tiral
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ERAS group

ERAS group was consisted of evidenced-based systematic optimization approaches

Group Type EXPERIMENTAL

Enhanced recovery for SPK recipients

Intervention Type PROCEDURE

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

Traditional group

The control group received routine care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Enhanced recovery for SPK recipients

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Second affiliated hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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2020-hs-67

Identifier Type: -

Identifier Source: org_study_id

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