HODiVA: Postoperative Hyperbaric Oxygen Treatments to Reduce Complications in Diabetic Patients Undergoing Vascular Surgery

Sponsor

Karolinska Institutet (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01002209

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial aims to evaluate if hyperbaric oxygen treatment (HBO) given postoperatively is effective in reducing healing time and wound complications after lower extremity bypass surgery in patients with diabetes.

Hypothesis: Postoperative HBO treatment is effective in reducing complications in patients with diabetes undergoing peripheral vascular surgery

Condition or Disease	Intervention/Treatment	Phase
Diabetes Peripheral Arterial Disease Arterial Occlusive Disease	Procedure: Hyperbaric Oxygen treatment (HBO) Procedure: Sham HBO	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Postoperative Hyperbaric Oxygen Treatments to Reduce Complications in Diabetic Patients Undergoing Vascular Surgery (HODiVA) - A Double Blind, Randomized Controlled Study

Anticipated Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

Oct 1, 2020

Anticipated Study Completion Date :

Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Sham Hyperbaric Oxygen Treatment	Procedure: 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.
Experimental: Hyperbaric oxygen treatment (HBO)	Procedure: 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.

Arm

Intervention/Treatment

Sham Comparator: Sham Hyperbaric Oxygen Treatment

Procedure: 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.

Experimental: Hyperbaric oxygen treatment (HBO)

Procedure: 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.

Outcome Measures

Primary Outcome Measures

Time to complete healing of operative wounds [7-365 days]

Secondary Outcome Measures

Number of wound infections at 7 days assessed by ASEPSIS score. A score over 20 will be considered as a wound infection. [7 days (plus minus 3 days)]
Number of wound infections at 30 days assessed by ASEPSIS score. A score over 20 will be considered as a wound infection. [30 days (plus minus 3 days)]
The severity of wound infection defined as by ASEPSIS score: 0-10= satisfactory healing 11-20= disturbed healing 21-30= minor wound infection 31-40= moderate wound infection >40= severe wound infection. [highest score up to 30 days (plus minus 3 days)]
A combination of any wound infection and/or unhealed wounds at 30 days (combined endpoint). [30 days (plus minus 3 days)]
SF-36 score [7, 14, 28, 365 days (plus minus 3 days)]
Major amputation or death. This will be assessed as "amputation-free survival". A major amputation is defined as any ipsilateral amputation through or above the ankle. [0-365 days]
Tissue perfusion and oxygenation on dorsum of foot on operated extremity as assessed by Transcutaneous oximetry during normobaric air breathing and after 6 min normobaric 100% oxygen challenge [day 3-5, 7 and 14, 28, 365 (plus minus 3 days)]
HBO complications (confinement anxiety, barotrauma, oxygen convulsions) [During HBO treatment up to day 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients are eligible for inclusion if the following criteria are fulfilled
Informed consent obtained
Scheduled for lower extremity open vascular surgery
Diabetes treated with insulin or oral antidiabetic medicine
Age ≥ 18 years

Exclusion Criteria:

Contraindications to HBO therapy
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska University Hospital	Stockholm		Sweden	17176

Sponsors and Collaborators

Karolinska Institutet

Investigators

Study Director: Kerstin Brismar, Professor, Karolinska Institutet
Principal Investigator: Jonas Malmstedt, MD, Karolinska Institutet
Principal Investigator: Folke G Lind, MD, PhD, Karolinska Institutet
Principal Investigator: Sergiu Catrina, MD, PhD, Karolinska Institutet
Principal Investigator: Joy Roy, MD, PhD, Karolinska Institutet
Principal Investigator: Nils Pettersson, MD, PhD, Karolinska Institutet
Principal Investigator: Bengt M Eriksson, MD, Hyperbaric Medicine, Karolinska Univ Hosp