KCI AbThera for Hypertension

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Foothills Medical Centre, Calgary, Canada
Hypertension+5 More
KCI AbThera - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a commercial suction device can be used to remove peritoneal fluid in critically ill patients.

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Eligible Conditions

  • Hypertension
  • Abdominal Compartment Syndrome
  • Intra-abdominal Hypertension

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether KCI AbThera will improve 1 primary outcome and 2 secondary outcomes in patients with Hypertension. Measurement will happen over the course of admission to hospital discharge; expected average of hospital stay 4 weeks..

Week 4
Systemic inflammatory marker levels and peritoneal fluid inflammatory marker levels
Week 4
Physiological Outcomes
Month 6
Global Outcomes

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

"Stampede" VAC
1 of 2
KCI AbThera
1 of 2
Active Control
Experimental Treatment

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. KCI AbThera is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

KCI AbThera
Device
commercial AbThera vacuum assisted abdominal closure at 125 mmHg suction
"Stampede" VAC
Device
Calgary-home-made "Stampede" VAC system with only closed drain bulb suction

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: patients will be followed-up for 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly patients will be followed-up for 6 months for reporting.

Who is running the study

Principal Investigator
A. W. K.
Andrew W Kirkpatrick, MD
University of Calgary

Closest Location

Foothills Medical Centre - Calgary, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People who are critically ill or injured and require admission to an intensive care unit. show original
was done After the initial surgery, the doctors had to decide whether or not to use an open abdomen technique. show original
Age > 18
Non-pregnant

Patient Q&A Section

How many people get intra-abdominal hypertension a year in the United States?

"There was a large variation in the prevalence of IAH among the states. These states ranged from low and moderate to high rates of IAH. One can find the incidence of IAH in each state by using Population Health Facts. To get specific numbers, one can use the table in the Population Health Facts. The most common causes of IAH were hypertension and intra-abdominal trauma. In this article, as IAH occurs mainly through hypertension, treatment of hypertension is a potential management of IAH." - Anonymous Online Contributor

Unverified Answer

What are common treatments for intra-abdominal hypertension?

"IAP is not always treated. In most cases, the goal of treatment is not to cure IAH, but rather to decrease further harm to the patient. Although conservative treatment often is the treatment of choice, the role of surgery as a treatment option is an important aspect. Further research is needed to understand the role of surgery as a treatment option." - Anonymous Online Contributor

Unverified Answer

What is intra-abdominal hypertension?

"IAH is associated with increased mortality and short- and long-term morbidity due to increased catecholamine production and vasodilation, respectively. IAH is prevalent in critical patients in intensive care unit despite high hemodynamic and ventilation support or in patients without shock." - Anonymous Online Contributor

Unverified Answer

Can intra-abdominal hypertension be cured?

"It is difficult to determine whether intra-abdominal hypertension is not only relieved by decreasing intra-abdominal pressure, but also by reducing fluid resuscitation or by increasing blood pressure." - Anonymous Online Contributor

Unverified Answer

What causes intra-abdominal hypertension?

"IAH is a multifactorial condition where gastrointestinal motility, local perfusion and compliance effects with the intra-abdominal compartment play a substantial role. IAH can be attributed to many different causes e.g. intra-abdominal infections or mal-absorption with consequent mal-distribution of plasma volume (hypoperfusion)." - Anonymous Online Contributor

Unverified Answer

What are the signs of intra-abdominal hypertension?

"The symptoms of severe intra-abdominal hypertension involve abdominal pain, vomiting and nausea and hypotension. Intra-abdominal hypertension may also result in acute kidney injury. The combination of the criteria of the ACCP/SCCM/RSST Intravenous Guidelines may also be clinically useful for the diagnosis of severe intra-abdominal hypertension." - Anonymous Online Contributor

Unverified Answer

What is the latest research for intra-abdominal hypertension?

"IAH is an important factor associated with morbidity and mortality in trauma patients. This information may help us plan protocols for management and prevent adverse consequences of IAH in trauma patients." - Anonymous Online Contributor

Unverified Answer

How does kci abthera work?

"The use of Kci AB in high risk patients with intra-abdominal hypertension can be beneficial after appropriate risk analysis. Further prospective, randomized studies are needed to establish its role as a complementary therapy to conventional treatments." - Anonymous Online Contributor

Unverified Answer

Does kci abthera improve quality of life for those with intra-abdominal hypertension?

"Symptom scores were improved at 24 weeks, with no change in functional scores, in kci-treated patients when compared with baseline. No serious side effects were noted with kci treatment." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving kci abthera?

"This was the first clinical trial on abciximab. There were several other clinical trials involving abciximab using different dosing and injection routes, in combination with aspirin and with or without thrombolytic therapy." - Anonymous Online Contributor

Unverified Answer

Is kci abthera safe for people?

"Kci ABThera is not associated with abdominal pain when given for the treatment of postmenopausal women who are not pregnant or have had no prior history of gastrointestinal or perianal pain." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets intra-abdominal hypertension?

"Patients with IAH on average are aged around 70 years, making them on average, the second oldest with IAH (only behind the elderly) in the world. While this population has an approximate 2:1 risk of mortality from other causes, mortality from IAAH is exceedingly rare compared to IAH from other causes." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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