Intra-Abdominal Hypertension Clinical Trial
Official title:
The Prevalence, Incidence and Factors Associated With Intra-abdominal Hypertension Among Patients Admitted in Intensive Care Units in Uganda-a Multi Center Prospective Study
The study was carried out to determine the prevalence,incidence and factors associated with
intra-abdominal hypertension among patients admitted in three intensive care units in Kampala
Uganda.
It was a multi-center prospective cohort study carried out in three intensive care units
where 126 patients that met the eligibility criteria were included in the
study,demographics,of these were recorded and intra-abdominal pressure measured using the
intra-vesical technique at 0,24,and 72 hours.data entry was done using epi-data version
3.1.Data analysis is on going.
Research Question:
What is the prevalence, incidence and associated factors of intra-abdominal hypertension
among patients admitted in intensive care units in Uganda?
Rationale for research:
Intra-abdominal hypertension (IAH) is defined as intra-abdominal pressure greater than or
equal to 12mmHg. In the developed world, it has been found to be common among critically ill
patients and associated with high morbidity and mortality. The world society of Abdominal
Compartment Syndrome recommends routine screening for IAH of all critically ill patients upon
ICU admission.
Several factors have been arguably associated with intra-abdominal hypertension some of which
are common among the critically ill patients in our setting. However Intra-abdominal
hypertension has not been given due attention in Ugandan critical care units as evidenced by
paucity of data concerning its prevalence, low levels of awareness among critical care
medical staff, low levels of screening for IAH and limited routine measurement of
intra-abdominal pressure among patients admitted in these units.
Intra-abdominal hypertension if undetected results in multi-organ dysfunction, increased
length of ICU stay, morbidity, and mortality.
This study therefore seeks to determine the prevalence, incidence and risk factors of
intra-abdominal hypertension among the critically ill in Ugandan ICUs so as to create a basis
from which protocols to identify, prevent and manage it may be derived.
General objective:
To determine the incidence, prevalence and factors associated with intra-abdominal
hypertension among patients admitted in intensive care units in Uganda.
Specific objectives:
To determine the baseline 24 hour and 72 hour prevalence of intra-abdominal hypertension
among patients admitted in intensive care units in Uganda.
To determine the 24 hour and 72 hour incidence of intra-abdominal hypertension among patients
admitted in intensive care units in Uganda.
To determine factors associated with intra-abdominal hypertension among patients admitted in
the intensive care units in Uganda.
METHODS:
Research design: Multi-center prospective cohort study. This design was chosen in order to
achieve better representation of patients in intensive care units in Uganda. It s a
prospective study because currently there is paucity of data concerning the subject hence a
retrospective analysis could not be done. Also follow up of patients is required to assess
factors associated with intra-abdominal hypertension.
All patients admitted to the intensive care units will be recruited in the study. Patients'
demographics will be recorded at admission. A urinary catheter shall be inserted and intra
abdominal pressure measured at admission, 24 hours, and 72 hours. The patients will then be
followed up for 28 day mortality.
Study population:
Sample size: 111 Subjects' state of physical health: seriously ill.
Source of participating subjects:
Mulago National Referral intensive care unit Nakasero hospital limited intensive care unit
International Hospital Kampala intensive care unit.
Research procedures:
1. All patients admitted in the intensive care units of the study sites during the study
period shall be recruited in the study. A waiver of consent shall be obtained
2. All recruited patients shall be reviewed at T0, T24, and T72 hours T0 defined as 0-3
hours post ICU admission, T24 defined as 24 hours post ICU admission, and T72 as 72
hours post ICU admission.
3. During the study period, the principle investigator and /or research assistants using
the data collection tool attached will collect data on day of admission, T72 hours and
follow up patients for 28 day mortality.
4. Data collected will include: patients 'demographics, referral source, indication for ICU
admission, admission vital parameters, mode of ventilation, ventilation period, length
of ICU stay, date of death/discharge from the ICU, 24 hour and cumulative fluid balance
and intra-abdominal pressure measurements.
5. The patients shall be catherized using a three way Foleys catheter, the urinary bladder
drained and 25mls of normal saline instilled in the bladder. The tubing of the
collecting bag will be clamped and the catheter connected to a saline manometer. The
pressure will then be measured in centimeters of water at the end of expiration. This
will be done at T0, T24 and T72 hours.
6. The patients will then be followed up for 28 day ICU mortality, length of stay in the
ICU, and duration of ventilation.
Risks/benefits:
Intra-abdominal pressure measurement using the intra-vesical (bladder) technique is a safe
and acceptable procedure worldwide and no complications have been noted.
The intensivists in charge of the units will be notified about patients found to have
intra-abdominal hypertension and they will decide the management fit for each patient.
Confidentiality assurances:
1. The patients' identification will be by IP numbers and not individual names
2. The data collected will be saved in multiple storage devices and stored in secure places
such as drop box.
3. All saved data copies will be updated on a weekly basis and resaved.
Conflict of interest:
The principle investigator has no conflict of interest.
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