Donor nephrectomy for Kidney Disease

N/A

Recruiting

Led By Uzong Yoon, MD, MPH

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from arrival to pacu until post-operative day 2 (48 hours)

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to study the effectiveness of an ERAS pathway for patients undergoing living donor nephrectomy. The hypothesis is that this will lead to faster recovery, early bowel function, decreased postoperative pain, increased patient satisfaction and shorter length of stay.

Eligible Conditions

Kidney Disease
Infections
Postoperative Complications
Postoperative Nausea and Vomiting
Opioid Use Disorder
Postoperative Pain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from arrival to pacu until post-operative day 2 (48 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from arrival to pacu until post-operative day 2 (48 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from arrival to pacu until post-operative day 2 (48 hours) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

post operative opioid consumption

Secondary study objectives

duration of hospitalization

patient satisfaction

time to first oral intake

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Enhanced recovery after surgeryExperimental Treatment5 Interventions

Preoperatively, patients will be counseled on optimization of physical and nutritional status. They will receive carbohydrate loading drinks prior to surgery. Intraoperatively, standard ASA monitors will be utilized, and patients will receive general anesthesia. Goal directed fluid management will be enforced with bolus options based on hemodynamics. Transabdominal plane and rectus sheath block will be performed in the operating room by the regional anesthesia team. Post-operatively pain management will include multimodal analgesic medications. Regular diet will be allowed and encouraged on post-operative day 0 (POD). Lines and drains will be minimized to encourage early mobilization and bowel function. Patients will be counseled on expectations of discharge criteria POD0.

Group II: Standard of careActive Control1 Intervention

Patients will receive traditional care for donor nephrectomy. Patients will be instructed to fast for 24 hours preoperative. On day of surgery, standard monitors will be used, and intraoperative management per anesthesiologists discretion including pain management. Post-operative, patients will receive pain medications, including opioids, as needed. Intravenous fluids will be continued until patients tolerate liquids per os. Bowel regimen will be ordered as needed. Patients will be discharged once meeting pre-set criteria.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

regional anesthesia

2009

Completed Phase 3

~64380

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