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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2009 by Karolinska Institutet
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01002209
First received: October 26, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Time to complete healing of operative wounds [ Time Frame: 7-365 days ] [ Designated as safety issue: No ]

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. [ Time Frame: 7 days (plus minus 3 days) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: highest score up to 30 days (plus minus 3 days) ] [ Designated as safety issue: No ]
  • A combination of any wound infection and/or unhealed wounds at 30 days (combined endpoint). [ Time Frame: 30 days (plus minus 3 days) ] [ Designated as safety issue: No ]
  • SF-36 score [ Time Frame: 7, 14, 28, 365 days (plus minus 3 days) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • HBO complications (confinement anxiety, barotrauma, oxygen convulsions) [ Time Frame: During HBO treatment up to day 6 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 112
Study Start Date: October 2009
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002209

Contacts
Contact: Kerstin Brismar, MD, Prof +46 8 517 70000 kerstin.brismar@ki.se
Contact: Jonas Malmstedt, MD +46 8 517 70000 jonas.malmstedt@karolinska.se

Locations
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, 17176
Sub-Investigator: Joy Roy, MD, PhD         
Sub-Investigator: Nils Pettersson, MD, PhD         
Sub-Investigator: Folke Lind, MD, PhD         
Sub-Investigator: Jonas Malmstedt, MD         
Sub-Investigator: Sergiu Catrina, MD, PhD         
Principal Investigator: Kerstin Brismar, MD, Prof         
Sub-Investigator: Bengt M Eriksson, MD         
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
  More Information

No publications provided

Responsible Party: Kerstin Brismar, MD, PhD, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01002209     History of Changes
Other Study ID Numbers: HODIVA
Study First Received: October 26, 2009
Last Updated: October 26, 2009
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Diabetes
Vascular Surgery
Hyperbaric oxygen
Surgical complications
Wound complication
Randomized
Controlled

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014