Postoperative Hyperbaric Oxygen Treatments to Reduce Complications in Diabetic Patients Undergoing Vascular Surgery
NCT ID: NCT01002209
Last Updated: 2020-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2/PHASE3
INTERVENTIONAL
2019-10-31
2020-10-31
Brief Summary
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Hypothesis: Postoperative HBO treatment is effective in reducing complications in patients with diabetes undergoing peripheral vascular surgery
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sham Hyperbaric Oxygen Treatment
Sham HBO
HBO sham treatment will start on first postoperative day (study day 1). HBO sham treatment will be given twice daily first three days (study day 1-3) and then once daily for up to three days (study day 4-6). The total number of treatments will be at least 6 and at most 9 treatments. Patients who have received at least three days HBO sham treatments and who have a clearly uncomplicated postoperative course will terminate HBO sham treatment on the day of discharge from hospital.
For patient blinding purposes, the sham group will breathe air and will be given a brief compression to 1.5 bar at the beginning of each treatment after which the chamber is slowly decompressed to 1.1, 1.2 , 1.3, or 1.4 bar corresponding to 0.23 ,0.25, 0.27, and 0.29 bar inspired oxygen. Two 10 min "airbrakes" will also be included.
Hyperbaric oxygen treatment (HBO)
Hyperbaric Oxygen treatment (HBO)
HBO treatment will be given in a monoplace chamber and will start on first postoperative day (study day 1). The HBO group will be treated with 100% oxygen at 2.5 bar for 100 min with two 10 min airbrakes (without mask).
HBO treatment will be given twice daily first three days (study day 1-3) and then once daily for up to three days (study day 4-6). The total number of treatments will be at least 6 and at most 9 treatments. Patients who have received at least three days HBO/placebo treatment and who have a clearly uncomplicated postoperative course will terminate HBO/placebo treatment on the day of discharge from hospital.
Interventions
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Hyperbaric Oxygen treatment (HBO)
HBO treatment will be given in a monoplace chamber and will start on first postoperative day (study day 1). The HBO group will be treated with 100% oxygen at 2.5 bar for 100 min with two 10 min airbrakes (without mask).
HBO treatment will be given twice daily first three days (study day 1-3) and then once daily for up to three days (study day 4-6). The total number of treatments will be at least 6 and at most 9 treatments. Patients who have received at least three days HBO/placebo treatment and who have a clearly uncomplicated postoperative course will terminate HBO/placebo treatment on the day of discharge from hospital.
Sham HBO
HBO sham treatment will start on first postoperative day (study day 1). HBO sham treatment will be given twice daily first three days (study day 1-3) and then once daily for up to three days (study day 4-6). The total number of treatments will be at least 6 and at most 9 treatments. Patients who have received at least three days HBO sham treatments and who have a clearly uncomplicated postoperative course will terminate HBO sham treatment on the day of discharge from hospital.
For patient blinding purposes, the sham group will breathe air and will be given a brief compression to 1.5 bar at the beginning of each treatment after which the chamber is slowly decompressed to 1.1, 1.2 , 1.3, or 1.4 bar corresponding to 0.23 ,0.25, 0.27, and 0.29 bar inspired oxygen. Two 10 min "airbrakes" will also be included.
Eligibility Criteria
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Inclusion Criteria
* Informed consent obtained
* Scheduled for lower extremity open vascular surgery
* Diabetes treated with insulin or oral antidiabetic medicine
* Age ≥ 18 years
Exclusion Criteria
* Pregnancy (women of childbearing potential will undergo pregnancy test before inclusion)
* Patients already in HBO treatment
* Vascular reoperation
* Creatinine \> 250 mmol/L
* NYHA class IV heart failure or severe cardiopulmonary disease with desaturation judged to be incompatible with safe HBO/ placebo therapy in a monoplace chamber
* Clinically significant chronic obstructive pulmonary disease.
* Acute sepsis.
* Malignancy or other serious medical condition where it is likely that the patient will significantly deteriorate or not survive within the two years of follow up.
* Simultaneous or previous (within 30 days prior to study entry participation in a clinical study using experimental drugs or devices.
* Mental condition making the subject unable to understand the concepts and risk of the study
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Principal Investigators
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Kerstin Brismar, Professor
Role: STUDY_DIRECTOR
Karolinska Institutet
Jonas Malmstedt, MD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Folke G Lind, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Sergiu Catrina, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Joy Roy, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Nils Pettersson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Bengt M Eriksson, MD
Role: PRINCIPAL_INVESTIGATOR
Hyperbaric Medicine, Karolinska Univ Hosp
Locations
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Karolinska University Hospital
Stockholm, , Sweden
Countries
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Other Identifiers
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HODIVA
Identifier Type: -
Identifier Source: org_study_id