Intraabdominal HypertensionNCT03762057
Prevalence, Risk Factors, and Prognostic Factors of Intraabdominal Hypertension and Abdominal Compartment Syndrome in Critically Ill Surgical Patients in Ramathibodi Hospital
An observational study of Intraabdominal Hypertension and Abdominal Compartment Syndrome, run by Ramathibodi Hospital at 1 site in Thailand.
Trial summary
To identified prevalence, risk factors, and prognostic factors of IAH and ACS in surgical critically ill patients in institutional hospital Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraabdominal Hypertension, Abdominal Compartment Syndrome
- What is being tested?
- Intraabdominal pressure monitoring
- How many people
- 303 participants
- Where
- 1 siteThailand
- Study dates
- 10 Dec 2018to 10 Jun 2020
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All postoperative adult patients admitted to institutional surgical ICUs.
Who may be able to join
- Postoperative patient admitted to surgical ICU
- Age >/= 18
- Foley's catheter in place
Who cannot join
- Patient refusal
- Underwent neo-bladder procedure
- Need continuous bladder irrigation
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Ramathibodi Hospital
Ratchathewi, Bangkok, 10400
Cherdkiat Karnjanarachata, MD, +66-85-5774747, chird_na@yahoo.com
Cherdkiat Karnjanarachata, MD
About this study
To identified prevalence, risk factors, and prognostic factors of IAH and ACS in surgical critically ill patients in institutional hospital
Read the detailed description
Every postoperative patients admitted to surgical ICU who meet inclusion criteria will be asked for informed consent. After obtained, intraabdominal pressure (IAP) will be measured through already placed Foley's catheter simultaneously with patients's data record. If patients don't have IAH or ICS, IAP will be measured daily until discharge from ICU or removal of Foley's catheter. If patients have IAH or ACS, IAP will be measured every 6-8 hours until IAP is less than 12 mmHg then it will be measures daily until discharge from ICU or removal of Foley's catheter. After completion of data collection, data will be analyzed accordingly.
- Being tested
- Intraabdominal pressure monitoring
- Keywords
- Intraabdominal Hypertension, Abdominal Compartment Syndrome, Prevalence, Risk factors, ICU, Surgical
- Medical subject headings
- Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraabdominal pressure monitoringDiagnostic test
Classic manometry technique measurement once daily
| Study group | Role | What they receive |
|---|---|---|
| Surgical patients | All postoperative patients admitted to surgical ICU with foley catheter in place Receives: Diagnostic Test: Intraabdominal pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of intraabdominal hypertension and abdominal compartment syndrome
Prevalence of intraabdominal hypertension and abdominal compartment syndrome
Measured: Within 30 days of ICU admission
Secondary outcomes (2)
Risk factors of intraabdominal hypertension and abdominal compartment syndrome
Risk factors of intraabdominal hypertension and abdominal compartment syndrome
Measured: Within 30 days of ICU admission
Prognostic factors of death after developing intraabdominal hypertension and abdominal compartment syndrome
Prognostic factors of death after developing intraabdominal hypertension and abdominal compartment syndrome
Measured: Within 30 days of ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start10 Dec 2018 (estimated)
- Primary completion10 Dec 2019 (estimated)
- Study completion10 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraabdominal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 303 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cherdkiat karnjanarachata, Ramathibodi Hospital
- Investigators
- Cherdkiat Karnjanarachata, MD, Principal investigator, Faculty of medicine, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762057
- Sponsor's protocol ID
- CK999
- Status last verified
- Nov 2018
- First submitted
- 30 Nov 2018
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Risk Factors, and Prognostic Factors of Intraabdominal Hypertension and Abdominal Compartment Syndrome in Critically Ill Surgical Patients in Ramathibodi Hospital
- ClinicalTrials.gov ID
- NCT03762057
- Acronym / sponsor ID
- CK999
- Keywords
- Intraabdominal Hypertension, Abdominal Compartment Syndrome, Prevalence, Risk factors, ICU, Surgical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 303 participants (estimated)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- 10 Dec 2018 (estimated)
- Primary completion
- 10 Dec 2019 (estimated)
- Study completion
- 10 Jun 2020 (estimated)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To identified prevalence, risk factors, and prognostic factors of IAH and ACS in surgical critically ill patients in institutional hospital
Detailed description
Every postoperative patients admitted to surgical ICU who meet inclusion criteria will be asked for informed consent. After obtained, intraabdominal pressure (IAP) will be measured through already placed Foley's catheter simultaneously with patients's data record. If patients don't have IAH or ICS, IAP will be measured daily until discharge from ICU or removal of Foley's catheter. If patients have IAH or ACS, IAP will be measured every 6-8 hours until IAP is less than 12 mmHg then it will be measures daily until discharge from ICU or removal of Foley's catheter. After completion of data collection, data will be analyzed accordingly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical patients | – | Diagnostic Test: Intraabdominal pressure monitoringAll postoperative patients admitted to surgical ICU with foley catheter in place |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All postoperative adult patients admitted to institutional surgical ICUs.
Key inclusion criteria (3 listed)
- Postoperative patient admitted to surgical ICU
- Age >/= 18
- Foley's catheter in place
Key exclusion criteria (3 listed)
- Patient refusal
- Underwent neo-bladder procedure
- Need continuous bladder irrigation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraabdominal pressure monitoringClassic manometry technique measurement once daily | Diagnostic test | Surgical patients |
Primary outcome
Prevalence of intraabdominal hypertension and abdominal compartment syndrome
Time frame: Within 30 days of ICU admission
Prevalence of intraabdominal hypertension and abdominal compartment syndrome
2 secondary outcomes
Risk factors of intraabdominal hypertension and abdominal compartment syndrome
Time frame: Within 30 days of ICU admission
Prognostic factors of death after developing intraabdominal hypertension and abdominal compartment syndrome
Time frame: Within 30 days of ICU admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cherdkiat Karnjanarachata, MD principal investigator
Faculty of medicine, Ramathibodi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraabdominal Hypertension and Abdominal Compartment Syndrome, run by Ramathibodi Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cherdkiat Karnjanarachata, MD (+66-85-5774747, chird_na@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of intraabdominal hypertension and abdominal compartment syndrome (time frame: Within 30 days of ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2018.