Skip to main content
OpenTrials
Completed

NCT Number: NCT03141385

Renal Effects of RIPC in Patients After Total Arch Replacement

The purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Kidney Injury Dialysis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC

Beijing, China

About this study

Acute kidney injury (AKI) is a well-recognized complication after cardio-thoracic surgeries and is associated with increased morbidity and mortality. Total arch replacement is reported with a relatively high incidence of post-operative AKI. In addition, few effective preventive or therapeutic interventions for AKI have been identified. A number of studies have now addressed renal protection as a primary outcome following RIPC. Because the mechanism of I/R injury are similar to those proposed for AKI after CPB, the purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients scheduled for total arch replacement
  • written informed consent

Exclusion criteria

  • pre-existing AKI
  • peripheral vascular disease affecting the upper limbs
  • hybrid total arch replacement
  • the history of kidney transplantation

Treatment and study plan

Remote Ischemic Preconditioning

Other

Remote ischemic preconditioning (RIPC) will be induced after the general anesthesia prior to the cardiopulmonary bypass by four cycles of right limber ischemia (5-min blood pressure cuff inflation to a pressure of 200mmHg or a pressure that is 50 mmHg higher than SAP and 5-min cuff deflation)

Control

Other

Four cycles of right upper limb pseudo ischemia and reperfusion, which will be induced by 5-minute blood pressure cuff inflation to a low pressure of 20 mmHg followed by 5-minute cuff deflated.

Primary outcomes

  1. Incidence of AKI within the 7 days after the surgery

    Time frame: Within 7 days after the surgery

    AKI defined by KDIGO criteria

Secondary outcomes

  1. Incidence of severe AKI (stage 2 and stage 3)

    Time frame: Within 7 days after the surgery

    severity defined by KDIGO criteria

  2. Renal replacement therapy

    Time frame: Within 30 days after the surgery

    the requirement for RRT during index hospital stay

  3. Mechanical ventilation duration

    Time frame: Within 30 days after the surgery

    duration of mechanical ventilation in the intensive care unit

  4. Length of intensive care unit stay

    Time frame: Within 30 days after the surgery

    length of stay on the intensive care unit

  5. In-hospital death

    Time frame: Within 30 days after the surgery

    in-hospital all-cause death

  6. Stroke

    Time frame: Within 30 days after the surgery

    new onset stroke during index hospital stay

  7. Paraplegia

    Time frame: Within 30 days after the surgery

    impairment in motor or sensory function of the lower extremities during index hospital stay

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

Renal Effects of Remote Ischemic Preconditioning in Patients After Total Arch Replacement

Acronym: RenRIPC-TAR

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 5, 2017
Registry last updated
Jul 11, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.