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

Primary Purpose

Diabetes, Peripheral Arterial Disease, Arterial Occlusive Disease

Status

Withdrawn

Phase

Phase 2

Locations

Sweden

Study Type

Interventional

Intervention

Hyperbaric Oxygen treatment (HBO)

Sham HBO

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Diabetes, Vascular Surgery, Hyperbaric oxygen, Surgical complications, Wound complication, Randomized, Controlled

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham Hyperbaric Oxygen Treatment

Hyperbaric oxygen treatment (HBO)

Arm Description

Outcomes

Primary Outcome Measures

Time to complete healing of operative wounds

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.

Number of wound infections at 30 days assessed by ASEPSIS score. A score over 20 will be considered as a wound infection.

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.

A combination of any wound infection and/or unhealed wounds at 30 days (combined endpoint).

SF-36 score

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.

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

HBO complications (confinement anxiety, barotrauma, oxygen convulsions)

Full Information

NCT ID

NCT01002209

First Posted

October 26, 2009

Last Updated

November 30, 2020

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT01002209

Brief Title

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

Acronym

HODiVA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Changes in the organisation

Study Start Date

October 2019 (Anticipated)

Primary Completion Date

October 2020 (Anticipated)

Study Completion Date

October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Peripheral Arterial Disease, Arterial Occlusive Disease

Keywords

Diabetes, Vascular Surgery, Hyperbaric oxygen, Surgical complications, Wound complication, Randomized, Controlled

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sham Hyperbaric Oxygen Treatment

Arm Type

Sham Comparator

Arm Title

Hyperbaric oxygen treatment (HBO)

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Hyperbaric Oxygen treatment (HBO)

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Sham HBO

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time to complete healing of operative wounds

Time Frame

7-365 days

Secondary Outcome Measure Information:

Title

Number of wound infections at 7 days assessed by ASEPSIS score. A score over 20 will be considered as a wound infection.

Time Frame

7 days (plus minus 3 days)

Title

Number of wound infections at 30 days assessed by ASEPSIS score. A score over 20 will be considered as a wound infection.

Time Frame

30 days (plus minus 3 days)

Title

Time Frame

highest score up to 30 days (plus minus 3 days)

Title

A combination of any wound infection and/or unhealed wounds at 30 days (combined endpoint).

Time Frame

30 days (plus minus 3 days)

Title

SF-36 score

Time Frame

7, 14, 28, 365 days (plus minus 3 days)

Title

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.

Time Frame

0-365 days

Title

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

Time Frame

day 3-5, 7 and 14, 28, 365 (plus minus 3 days)

Title

HBO complications (confinement anxiety, barotrauma, oxygen convulsions)

Time Frame

During HBO treatment up to day 6

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: