Intraoperative Fluid VolumeNCT05502835
Pulse Pressure Variation Based Intraoperative Fluid Management Versus Traditional Fluid Management for Colonic Cancer Patients Undergoing Mass Resection and Anastomosis
A study testing pulse pressure variation and conventional fluid management in people with Intraoperative Fluid Volume and Hemodynamics, run by Ain Shams University at 1 site in Egypt.
Trial summary
pulse pressure variation based intraoperative fluid therapy versus traditional fluid therapy for colonic cancer patients undergoing mass resection and anastomosis for maintaining adequate hydration without complications. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intraoperative Fluid Volume, Hemodynamics, Serum Lactate
- What is being tested?
- pulse pressure variation and conventional fluid management
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2022to 25 Jan 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status (ASA-PS) I and II Patients.
- Patients scheduled for elective open colonic mass resection and anastomosis.
Who cannot join
- Serious cardiac arrhythmia.
- Peripheral artery disease.
- An ejection fraction below 30%.
- A pulmonary pathology.
Trial locations and contacts
1 site in 1 country.
About this study
pulse pressure variation based intraoperative fluid therapy versus traditional fluid therapy for colonic cancer patients undergoing mass resection and anastomosis for maintaining adequate hydration without complications.
Read the detailed description
All Patients will be assigned randomly by using computerized program to one of the two equal groups. Patients will be (forty five patients per group):
Group A ;( control group) Forty five patients will do elective open colonic mass resection and anastomosis. Infusion of 6 ml/kg/hr. Ringer's solution.
Group B; Forty five patients will do elective open colonic mass resection and anastomosis. Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.
Intraoperative fluid volume, hemodynamics, serum lactate and intestinal edema will be measured after induction of anesthesia and every hour till the end of the operation, length of the hospital stay, first time to gastrointestinal motion and postoperative complications are recorded.
- Conditions
- Intraoperative Fluid Volume, Hemodynamics, Serum Lactate, Intestinal Edema, Length of the Hospital Stay, First Time to Gastrointestinal Motion
- Being tested
- pulse pressure variation, conventional fluid management
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulse pressure variationDevice
Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.
conventional fluid managementOther
Infusion of 6 ml/kg/hr. Ringer's solution.
| Study group | Role | What they receive |
|---|---|---|
| conventional fluid management group | Experimental | patients will do elective open colonic mass resection and anastomosis will receive Infusion of 6 ml/kg/hr. Ringer's solution. Receives: Other: conventional fluid management |
| ppv group | Active comparator | patients will do elective open colonic mass resection and anastomosis. Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation. Receives: Device: pulse pressure variation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative fluid volume
Measured: calculated immediately after surgery
Secondary outcomes (4)
intraoperative blood pressure
Measured: every ten minutes till the end of the surgery
lactate level
Measured: every hour till the end of the surgery
POSTOPERATIVE COMPLICATIONS
Measured: till one week after surgery
intestinal oedema
Measured: intraoperatively after tumor resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start20 Aug 2022
- Primary completion20 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Fluid VolumeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMY AHMED, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502835
- Sponsor's protocol ID
- IRB00006379 GUT OEDEMA
- Status last verified
- Jan 2023
- First submitted
- 2 Aug 2022
- Last updated
- 30 Jan 2023
- Results posted
- 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 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Pressure Variation Based Intraoperative Fluid Management Versus Traditional Fluid Management for Colonic Cancer Patients Undergoing Mass Resection and Anastomosis
- ClinicalTrials.gov ID
- NCT05502835
- Acronym / sponsor ID
- IRB00006379 GUT OEDEMA
- Conditions
- Intraoperative Fluid Volume, Hemodynamics, Serum Lactate, Intestinal Edema, Length of the Hospital Stay, First Time to Gastrointestinal Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 16 Aug 2022 (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.
pulse pressure variation based intraoperative fluid therapy versus traditional fluid therapy for colonic cancer patients undergoing mass resection and anastomosis for maintaining adequate hydration without complications.
Detailed description
All Patients will be assigned randomly by using computerized program to one of the two equal groups. Patients will be (forty five patients per group):
Group A ;( control group) Forty five patients will do elective open colonic mass resection and anastomosis. Infusion of 6 ml/kg/hr. Ringer's solution.
Group B; Forty five patients will do elective open colonic mass resection and anastomosis. Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.
Intraoperative fluid volume, hemodynamics, serum lactate and intestinal edema will be measured after induction of anesthesia and every hour till the end of the operation, length of the hospital stay, first time to gastrointestinal motion and postoperative complications are recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional fluid management group | Experimental | Other: conventional fluid managementpatients will do elective open colonic mass resection and anastomosis will receive Infusion of 6 ml/kg/hr. Ringer's solution. |
| ppv group | Active comparator | Device: pulse pressure variationpatients will do elective open colonic mass resection and anastomosis. Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status (ASA-PS) I and II Patients.
- Patients scheduled for elective open colonic mass resection and anastomosis.
Key exclusion criteria (4 listed)
- Serious cardiac arrhythmia.
- Peripheral artery disease.
- An ejection fraction below 30%.
- A pulmonary pathology.
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 |
|---|---|---|
| pulse pressure variationInfusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation. | Device | ppv group |
| conventional fluid managementInfusion of 6 ml/kg/hr. Ringer's solution. | Other | conventional fluid management group |
Primary outcome
Intraoperative fluid volume
Time frame: calculated immediately after surgery
4 secondary outcomes
intraoperative blood pressure
Time frame: every ten minutes till the end of the surgery
lactate level
Time frame: every hour till the end of the surgery
POSTOPERATIVE COMPLICATIONS
Time frame: till one week after surgery
intestinal oedema
Time frame: intraoperatively after tumor resection
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 30 Jan 2023.
- 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.
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 pulse pressure variation and conventional fluid management in people with Intraoperative Fluid Volume and Hemodynamics, run by Ain Shams 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 2 inclusion and 4 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 30 Jan 2023. 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?
Intraoperative fluid volume (time frame: calculated immediately after surgery). 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 30 Jan 2023.