NCT02743754

Hyperbaric Oxygen Therapy for Cardiac Surgery-Associated Acute Kidney Injury: A First-in-Human Pilot Study

Terminated NA Last updated 15 May 2019

What this trial tests

NA trial testing Standard therapy in Acute Kidney Injury in 7 participants. Terminated before completion.

Timeline

10 June 2016

Primary endpoint
7 September 2017

1 May 2019

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	10 June 2016
Primary completion	7 September 2017
Estimated completion	1 May 2019
Sites	1 location across Canada

Drugs / interventions tested

• Standard therapy — full drug profile →
• Hyperbaric Oxygen — full drug profile →

Conditions studied

• Acute Kidney Injury — all drugs for Acute Kidney Injury →

Sponsor

University Health Network, Toronto

Who can join

18 and older, any sex, with Acute Kidney Injury. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.
• Safety of the intervention as assessed by adverse events
  Time frame: 7 days
  Adverse events that are related to the intervention.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.