Major Abdominal SurgeriesNCT04792242
Effect of PCO2 Gap Algorithm Application on Outcome of High Risk Surgical Patients Undergoing Major Abdominal Surgeries
A study testing cv line insertion, Urinary catheter insertion and Arterial line in people with Major Abdominal Surgeries, run by South Valley University at 1 site in Egypt.
Trial summary
1. Primary (main): Comparison between goal directed therapy and PCO2 gap algorithm (carbon dioxide partial pressure venous arterial gap algorithm) application on 30 days mortality and organ dysfunction post operative 2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Major Abdominal Surgeries
- What is being tested?
- cv line insertion, Urinary catheter insertion and Arterial line
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2019to 7 Mar 2021
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical criteria for high-risk surgical patients used by Shoemaker and colleagues and adapted by Boyd and colleagues
Who cannot join
- patients who will refuse to continue on research patients who will not be admitted post operative in the ICU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Goal Directed Therapy and PCO2 Gap Algorithm Application on Outcome of High Risk Surgical Patients Undergoing Major Abdominal Surgeries
- Primary (main): Comparison between goal directed therapy and PCO2 gap algorithm (carbon dioxide partial pressure venous arterial gap algorithm) application on 30 days mortality and organ dysfunction post operative
- Secondary (subsidiary):
Comparison between goal directed therapy and PCO2 gap algorithm application on number of ventilator dependant days, number of days on vasopressors or inotropes length of ICU stay, length of hospital stay,
Read the detailed description
High risk surgical participants in South valley university hospitals (teaching hospitals) who will undergo major abdominal surgeries will be included in research after giving written informed consent from the participants or from the patient's legal representative. The use of obtained data will be approved by local ethics committee.
All participants will be evaluated pre operatively and pre medicated according to protocols in our hospital, base line sequential organ failure (SOFA) score will be taken. General anesthesia for all patients will be carried on according to our local standards. As part of our routine hemodynamic monitoring during major surgery, all patients will be monitored with central venous (standard three-lumen catheter) and arterial catheters placed before the beginning of surgery. The central venous line will be positioned with the tip within the superior vena cava, and correct positioning will be verified by chest radiograph.
the participants will be divided randomly onto to groups using numerical system group A PCO2 gap algorithm(carbon dioxide partial pressure venous arterial gap) will be applied intraoperative and 12 h postoperative end point PCO2 gap 2-6mm Hg(appendix 1).
Group B goal directed therapy protocol which will include targets mean arterial blood pressure ( MAP) > 65 mmHg, central venous pressure(CVP) between 8-12 cmH2O , Haematocrite value more than 30, mixed venous oxygen saturation (Svo2) >75% and urine output more than >0.5 ml/kg/hr and will be applied intraoperative and 12 postoperative end point base deficit +/- 2(appendix 2 ).
All participants will be admitted to the ICU (intensive care unit) immediately after surgery .Standard postoperative monitoring will include: electrocardiograph (heart rate), invasive mean arterial pressure, pulse oxygen saturation and urine output then will be all managed according to their allocated group for 12 hours.
Outcomes in both groups will be recorded which will be number of ventilator dependant days, number of days on vasopressors or inotropes length of ICU stay, length of hospital stay, 30 days organ dysfunction, assessed by using the Sequential Organ Failure Assessment (SOFA) and 30 days mortality .
- Conditions
- Major Abdominal Surgeries
- Being tested
- cv line insertion, Urinary catheter insertion, Arterial line
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cv line insertionDevice
Svo2 and central venous pressure measurements
Urinary catheter insertionDevice
urine output measurement
Arterial lineDevice
Arterial blood gases measurment
| Study group | Role | What they receive |
|---|---|---|
| goal directed therapy | Active comparator | svo2,haematocrite value,urine output,mean arterial pressure and central venous pressure Receives: Device: cv line insertion; Device: Urinary catheter insertion |
| PCO2 gap algorithm | Active comparator | PCO2 gap,haematocrite value,Spo2,cardiac index Receives: Device: cv line insertion; Device: Urinary catheter insertion; Device: Arterial line |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative mortality
early post operative mortality
Measured: 30 days
Secondary outcomes (1)
post operative organ failure
cardiac,renal,respiratory,renal central nervous system(CNS) failure by sequential organ failure(SOFA) score
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start10 Nov 2019
- Primary completion21 Dec 2020
- Study completion7 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Abdominal SurgeriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- case control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Abdelsapour Abdelrazek, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792242
- Sponsor's protocol ID
- SVU.MED.AIP029.4.1
- Status last verified
- Mar 2021
- First submitted
- 7 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Goal Directed Therapy and PCO2 Gap Algorithm Application on Outcome of High Risk Surgical Patients Undergoing Major Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT04792242
- Acronym / sponsor ID
- SVU.MED.AIP029.4.1
- Conditions
- Major Abdominal Surgeries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 10 Nov 2019 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 7 Mar 2021 (actual)
- First posted
- 10 Mar 2021 (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.
- Primary (main): Comparison between goal directed therapy and PCO2 gap algorithm (carbon dioxide partial pressure venous arterial gap algorithm) application on 30 days mortality and organ dysfunction post operative
- Secondary (subsidiary):
Comparison between goal directed therapy and PCO2 gap algorithm application on number of ventilator dependant days, number of days on vasopressors or inotropes length of ICU stay, length of hospital stay,
Detailed description
High risk surgical participants in South valley university hospitals (teaching hospitals) who will undergo major abdominal surgeries will be included in research after giving written informed consent from the participants or from the patient's legal representative. The use of obtained data will be approved by local ethics committee.
All participants will be evaluated pre operatively and pre medicated according to protocols in our hospital, base line sequential organ failure (SOFA) score will be taken. General anesthesia for all patients will be carried on according to our local standards. As part of our routine hemodynamic monitoring during major surgery, all patients will be monitored with central venous (standard three-lumen catheter) and arterial catheters placed before the beginning of surgery. The central venous line will be positioned with the tip within the superior vena cava, and correct positioning will be verified by chest radiograph.
the participants will be divided randomly onto to groups using numerical system group A PCO2 gap algorithm(carbon dioxide partial pressure venous arterial gap) will be applied intraoperative and 12 h postoperative end point PCO2 gap 2-6mm Hg(appendix 1).
Group B goal directed therapy protocol which will include targets mean arterial blood pressure ( MAP) > 65 mmHg, central venous pressure(CVP) between 8-12 cmH2O , Haematocrite value more than 30, mixed venous oxygen saturation (Svo2) >75% and urine output more than >0.5 ml/kg/hr and will be applied intraoperative and 12 postoperative end point base deficit +/- 2(appendix 2 ).
All participants will be admitted to the ICU (intensive care unit) immediately after surgery .Standard postoperative monitoring will include: electrocardiograph (heart rate), invasive mean arterial pressure, pulse oxygen saturation and urine output then will be all managed according to their allocated group for 12 hours.
Outcomes in both groups will be recorded which will be number of ventilator dependant days, number of days on vasopressors or inotropes length of ICU stay, length of hospital stay, 30 days organ dysfunction, assessed by using the Sequential Organ Failure Assessment (SOFA) and 30 days mortality .
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- case control
| Arm | Type | Receives |
|---|---|---|
| goal directed therapy | Active comparator | Device: cv line insertion, Device: Urinary catheter insertionsvo2,haematocrite value,urine output,mean arterial pressure and central venous pressure |
| PCO2 gap algorithm | Active comparator | Device: cv line insertion, Device: Urinary catheter insertion, Device: Arterial linePCO2 gap,haematocrite value,Spo2,cardiac index |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical criteria for high-risk surgical patients used by Shoemaker and colleagues and adapted by Boyd and colleagues
Key exclusion criteria (1 listed)
- patients who will refuse to continue on research patients who will not be admitted post operative in the ICU
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 |
|---|---|---|
| cv line insertionSvo2 and central venous pressure measurements | Device | PCO2 gap algorithm, goal directed therapy |
| Urinary catheter insertionurine output measurement | Device | PCO2 gap algorithm, goal directed therapy |
| Arterial lineArterial blood gases measurment | Device | PCO2 gap algorithm |
Primary outcome
Post operative mortality
Time frame: 30 days
early post operative mortality
1 secondary outcome
post operative organ failure
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cv line insertion, Urinary catheter insertion and Arterial line in people with Major Abdominal Surgeries, run by South Valley University at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Mar 2021. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative mortality (time frame: 30 days). 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 23 Mar 2021.