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Completed

NCT Number: NCT06095544

Enhanced Recovery After Surgery for SPK Transplantation Recipients

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.

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Key information

Conditions

Transplant Complication Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Diabetic Nephropathy Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative/Postoperative Complications Postoperative Complications Urogenital Diseases Urologic Diseases

Age range

20 year–62 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second affiliated hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced recovery for SPK recipients

Procedure

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

Primary outcomes

  1. 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)

  2. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 23, 2023
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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