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Completed

NCT Number: NCT04529005

Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant Recipients

The current standard of catecholamine vasopressor management of perioperative hypotension in kidney transplant patients carries significant risks and falls short in many ways. Currently, there is an absence in the scientific literature and research describing the hemodynamic effectiveness and safety of novel pharmacologic agents such as angiotensin II (Giapreza - Ang II) in perioperative kidney transplant patients. Phase 3 registration trials have demonstrated the superior safety and efficacy of Ang II (Giapreza) in distributive shock patients compared to traditional vasopressor agents and the novel mechanism of action may provide additional protection in renal transplant patients. The pilot study entails giving informed and consenting kidney transplant recipients Ang II (Giapreza) as their first vasopressor if the need for vasopressors emerge either intraoperatively or postoperatively in kidney transplant recipients. The primary objective is to evaluate the safety and hemodynamic effects of Ang II (Giapreza) in the renal transplant population.

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Key information

Conditions

Shock, Surgical Cardiovascular Diseases Hypotension Hypotension and Shock Intraoperative Hypotension Kidney Transplant; Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hypotension Shock Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Illinois Hospital and Health Sciences System

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients > 18 years of age
  • Receiving deceased donor kidney transplant
  • Pre-transplant Ejection Fraction (within past 18 months) > 50%
  • Intraoperative or postoperative distributive shock (according to hospital and study protocol) requiring vasopressor support

Exclusion criteria

  • Pregnant patients (they would be excluded from receiving a transplant)
  • Prisoners
  • History of mesenteric ischemia
  • History of aortic dissection
  • History of abdominal aortic aneurysm
  • Allergy to mannitol
  • Absolute neutrophil count < 1000 cell/mm3 (within past 18 months)
  • Diagnosis of Raynaud's phenomenon, systemic sclerosis or vasospastic disease

Treatment and study plan

Angiotensin II

Drug

If intraoperative or postoperative hypotension occurs (e.g. SBP < 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management.

Primary outcomes

  1. Duration of ATII Vasopressor Usage in the Intraoperative Setting

    Time frame: Duration of usage during the transplant surgery - presented in hours

    Duration of vasopressor usage while in the operating room measured in hours of usage presented as median and IQR.

Secondary outcomes

  1. Number (and Percentage) of Patients With Arrhythmias

    Time frame: From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.

    The presence of arrhythmia was confirmed via EKG, flowsheet, or note documentation from the electronic medical record.

  2. Number (and Percentage) of Patients With Peripheral/Visceral Ischemia

    Time frame: From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.

    The presence of digital or other peripheral/visceral ischemia was captured from reviewing chart documentation for each patient.

  3. Number (and Percentage) of Patients With Thrombosis

    Time frame: From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.

    Incidence of venous or arterial thrombosis occurring during the hospitalization for kidney transplant (captured by ultrasound or other diagnostic imaging)

  4. Number (and Percentage) of Patients With Fungal Infections

    Time frame: From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.

    The presence of post-operative fungal infections were captured prior to discharge as documented by the clinical care team in the electronic medical record.

  5. Number (and Percentage) of Patients With Hyperglycemia

    Time frame: From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.

    The presence of hyperglycemia was captured for each patient and was determined by those patients requiring the use of an insulin infusion after their transplant surgery.

  6. Number (and Percentage) of Patients With Delayed Graft Function

    Time frame: From post-op to 7 days post-op

    The presence of Delayed Graft Function was captured for each patient and defined by the need for renal replacement therapy up to 7 days post-operative.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • La Jolla Pharmaceutical Company

Registry information

Official study title

Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 27, 2020
Registry last updated
Dec 21, 2022

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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