Peritoneal Vacuum Therapy to Reduce Inflammatory Response From Abdominal Sepsis/Injury

NCT01355094 | Completed

• 1 other identifier: E-23706
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will evaluate the effectiveness in actively removing the peritoneal fluid through the use of a commercial suction device compared to passive drainage of the same peritoneal fluid drained through standard surgical drains under bulb suction only, in critically ill patients who require an "open abdomen". Both techniques being used, the commercial KCI AbThera™ device and home made "Stampede" VAC system, are currently approved for use in Canada and used in our facility. The use or non-use of the open abdomen and its relationship to intra-abdominal hypertension (IAH) and the abdominal compartment syndrome (ACS), the level of IAH must be treated and if so how should be treated - remain controversial. The ultimate treatment for IAH/ACS is to leave the abdominal fascia open after laparotomy, utilizing some form of temporary abdominal closure (TAC) techniques, resulting in an "open abdomen"(OA). The decision to accept an OA can only be made in the operating room and is typically made quite arbitrarily (there is no current standard or protocol),and the TAC used is based on the surgeon's best judgment. The study intends to randomize patients after it has been decided that a TAC is required, which will be applied in the operating room while the patient is fully anesthetized. The only intervention required is to obtain small aliquots (a teaspoonful-15ml) of blood for the evaluation of inflammatory mediators levels, as well as the same volume of intra-peritoneal fluid-that is typically discarded in patients with OA.

Conditions

Abdominal Compartment Syndrome; Intra-abdominal Hypertension

Keywords

temporary abdomen closure; peritoneal vacuum therapy; open abdomen; abdominal compartment syndrome; intra-abdominal sepsis; intra-abdominal hypertension; critical care

Outcome Measures

Primary Outcomes (1)

• Systemic inflammatory marker levels and peritoneal fluid inflammatory marker levels

  Intra-peritoneal and plasma inflammatory mediators will be measured on a treatment allocation basis immediately after initiation of the TAC, and thereafter at 2, 3, 7 and 28 days. The mediators studied will include, but are not limited to TNF-α, IL-1β, IL-6, IL-10, IL-12, and CRP.

  admission to dicharge, expected average of hospital stay 4 weeks.

Secondary Outcomes (2)

• Physiological Outcomes

  admission to hospital discharge; expected average of hospital stay 4 weeks.

• Global Outcomes

  patients will be followed-up for 6 months

Study Arms (2)

"Stampede" VAC

ACTIVE COMPARATOR

Calgary-home-made "Stampede" VAC system with only closed drain bulb suction

Device: "Stampede" VAC

KCI AbThera

EXPERIMENTAL

commercial AbThera vacuum assisted abdominal closure at 125 mmHg suction

Device: KCI AbThera

Interventions

KCI AbThera DEVICE

The time that the dressing will be left in place will be left to the discretion of the attending surgeon, but revised practice guidelines mandate either formal abdominal closure or dressing change at 24-96 hours from placement. Upon the first OA dressing change, the surgeon is free to utilize whatever temporary closure they choose. Just prior to placement of the dressing, 16 ml (1 table spoon) of blood will be drawn from an existing arterial or venous line (this will qualify as Day 1). The same quantity of blood will be drawn on days 2, 3, 7 and 28 (or hospital discharge, whichever comes first). 15ml of peritoneal fluid will also be collected from the abdomen on the same days or until closure of the abdomen and removal of the dressing.

KCI AbThera

"Stampede" VAC DEVICE

The time that the dressing will be left in place will be left to the discretion of the attending surgeon, but revised practice guidelines mandate either formal abdominal closure or dressing change at 24-96 hours from placement. Upon the first OA dressing change, the surgeon is free to utilize whatever temporary closure they choose. Just prior to placement of the dressing, 16 ml (1 table spoon) of blood will be drawn from an existing arterial or venous line (this will qualify as Day 1). The same quantity of blood will be drawn on days 2, 3, 7 and 28 (or hospital discharge, whichever comes first). 15ml of peritoneal fluid will also be collected from the abdomen on the same days or until closure of the abdomen and removal of the dressing.

"Stampede" VAC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Critically ill/injured requiring intensive care unit admission
• Decision regarding the need to utilize an open abdomen technique after the first laparotomy
• Age \> 18
• Non-pregnant

You may not qualify if:

• Decision to formally close the abdomen after the initial laparotomy
• Patients receiving intra-peritoneal chemotherapy
• Pregnancy
• Age \< 18

Sponsors & Collaborators

• University of Calgary: lead
• 3M: collaborator
• Alberta Health services: collaborator

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

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MeSH Terms

Conditions

Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Andrew W Kirkpatrick, MD

  Canadian Trauma Trials Collaborative

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Trauma Services, CD, MD, FACS, FRCSC, MHSc

Study Record Dates

• First Submitted: May 12, 2011
• First Posted: May 17, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)