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Hyperbaric Oxygen Therapy and Acute Kidney Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02743754
Recruitment Status : Terminated
First Posted : April 19, 2016
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

Kidney injury is a serious complication of cardiac surgery that occurs in up to 30% of patients and increases the risk of adverse outcomes. Kidney injury initiates when oxygen supply to the kidney drops below levels that are needed for normal cellular function, causing tissue oxygen deficiency (hypoxia), activation of the inflammatory cascade, and oxidative stress. Together, these events further impair tissue oxygenation, culminating in impaired kidney function due to cellular injury and death.

There are no effective therapies for kidney injury after cardiac surgery, but there is evidence that recovery is possible if the processes of injury - i.e., impaired oxygen delivery, increased inflammatory response, and oxidative stress - are ameliorated soon after the onset of injury. Hyperbaric oxygen therapy (HBOT) - which entails the intermittent inhalation of 100% oxygen in a hyperbaric chamber at a pressure higher than one absolute atmosphere (> 760 mmHg) - has been shown to positively affect all of these processes (i.e., to improve tissue oxygenation, reduce inflammation, and reduce oxidative stress). Thus, we hypothesized that HBOT will reduce the severity of kidney injury after cardiac surgery if it is initiated soon after onset of injury. This hypothesis has not been tested in humans, but is supported by animal studies.

In this first-in-human, unblinded, controlled pilot trial, 20 adult patients who develop severe kidney injury soon after cardiac surgery will be randomized (after obtaining informed consent from the patient or surrogate) to standard-of-care or early HBOT. Severe kidney injury will be defined as a ≥30% drop in kidney function within 6 hours of surgery (as determined by change in creatinine from before surgery to Intensive Care Unit (ICU) admission). This degree of injury occurs in ~ 2% of patients and is associated with a 12-fold increase in the risk of complete kidney failure (requiring dialysis) or death. Patients will be excluded if they have any relative or absolute contraindications to HBOT (e.g., severe ventricular dysfunction, ventricular assist device, severe respiratory dysfunction, pneumothorax, bronchospasm).


Condition or disease Intervention/treatment Phase
Acute Kidney Injury Other: Standard therapy Other: Hyperbaric Oxygen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy for Cardiac Surgery-Associated Acute Kidney Injury: A First-in-Human Pilot Study
Actual Study Start Date : June 10, 2016
Actual Primary Completion Date : September 7, 2017
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Placebo Comparator: Standard Therapy
Standard supportive therapies for Acute Kidney Injury (AKI), which entail optimization of hemodynamics and hemoglobin levels.
Other: Standard therapy
The standard of care for improving oxygen delivery to the kidney. These may include blood transfusions for anemia, treatment of low blood pressure and oxygen for low blood oxygen levels.

Active Comparator: Standard Therapy and hyperbaric oxygen
Standard therapies and treated in the hyperbaric chamber within 12 hours of surgery. There will be 4 hyperbaric oxygen treatments in 48 hours (1 every 12 hours), each treatment will last 90 minutes with 100% oxygen at 2.4 atmospheres absolute (ATA).
Other: Standard therapy
The standard of care for improving oxygen delivery to the kidney. These may include blood transfusions for anemia, treatment of low blood pressure and oxygen for low blood oxygen levels.

Other: Hyperbaric Oxygen
The standard of care therapies and in addition will be treated in the hyperbaric chamber within 12 hours of surgery. There will be 4 hyperbaric oxygen treatments in 48 hours (1 every 12 hours), each treatment will last 90 minutes with 100% oxygen at 2.4 ATA.




Primary Outcome Measures :
  1. Feasibility of the intervention [ Time Frame: 7 days ]
    The proportion of patients qualified but not consented and the proportion of patients completing the study from each group.

  2. Safety of the intervention as assessed by adverse events [ Time Frame: 7 days ]
    Adverse events that are related to the intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18 years
  • any cardiac surgery with cardiopulmonary bypass surgery
  • ≥30% drop in kidney function within 6 hours of surgery (determined by change in creatinine from before surgery to ICU admission)

Exclusion Criteria:

  • Pre-existing renal dysfunction (creatinine > 177 µmol/L)
  • claustrophobia
  • seizure disorder
  • severe respiratory dysfunction (PaO2/fraction of inspired oxygen (FiO2) ratio <150 on 100% O2 and Peep of 10)
  • active asthma or bronchospasm
  • severe chronic obstructive pulmonary disease
  • history of spontaneous pneumothorax or untreated pneumothorax
  • congestive heart failure with left ventricular ejection fraction < 30%
  • evidence of ongoing myocardial ischemia
  • presence of ventricular assist device or intra-aortic balloon pump
  • chronic sinusitis
  • chronic/ acute otitis media or major ear drum trauma
  • current treatment with bleomycin, cisplatin, doxorubicin and disulfiram

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743754


Locations
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Canada, Ontario
Toronto General Hopsital University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Keyvan Karkouti, MD University Health Network, Toronto

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02743754    
Other Study ID Numbers: 15-9843
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases