Fluid TherapyNCT05487222
Goal Directed and Liberal Fluid Therapy
An observational study of Fluid Therapy, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim is to compare intraoperative goal directed fluid therapy (GDFT) versus liberal fluid therapy in patients undergoing elective colorectal surgery by using noninvasive electrical cardiometry. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fluid Therapy
- What is being tested?
- ICON
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2020to 20 Sep 2021
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: This prospective, randomized, controlled study was conducted after a written informed consent will be obtained from all participants
Who may be able to join
- • patients scheduled for elective colorectal surgery
- with (ASA) physical status I - II - of both gender aged 18-60 years old
- Hb >12 g/dl \& Hct >38%.
Who cannot join
- • Patient refusal
- Patients with major cardiovascular problems with ejection fraction < 40 %
- Renal impairment with serum creatinine >1.8 mg/dl .
- Patients with hepatic dysfunction and coagulopathy.
- Metabolic disorder, serum lactate > 4 mmol/L.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Goal Directed Fluid Therapy Compared to Liberal Fluid Therapy in Patients Subjected to Colorectal Surgery
The aim is to compare intraoperative goal directed fluid therapy (GDFT) versus liberal fluid therapy in patients undergoing elective colorectal surgery by using noninvasive electrical cardiometry. This study hypothesized that GDFT is better than liberal fluid therapy to provide sufficient intra-vascular fluid volume for adequate perfusion without impairing glycolcalyx function with fluid overload
Read the detailed description
Intraoperative fluid management for major abdominal and intestinal surgeries is quite important in terms of postoperative organ perfusion and complications. Many complications such as acute renal failure, hypotension, arrhythmia, and anastomosis leak may occur secondary to intraoperative hypovolemia whereas hypervolemia may cause pulmonary edema, postoperative pneumonia, prolonged mechanical ventilation, delayed wound healing, edema in the gastrointestinal system (GIS), and decreased GIS motility.
In the perioperative period, fluid therapy and gastrointestinal function may complement each other or complicate it. If fluid therapy is not optimal, it may cause delayed gastrointestinal function and avoid early oral intake. If gastrointestinal dysfunction develops in the perioperative period, it may lead to fluid and electrolyte loss and metabolic problems. Thus, the intraoperative fluid management of the patient is very important.
Accurate assessment of a patient's volume status is an important goal for the anesthetist in the operating theatre to achieve hemodynamic stability and adequate tissue oxygenation. Different intraoperative fluid management protocols are in use for this purpose. The most common one is conventional fluid management (CFM). Fluid replacement is managed according to clinical assessment and heart rate (HR), arterial blood pressure (ABP) and central venous pressure (CVP) monitorization.
While goal-directed fluid therapy (GDFT) is a perioperative strategy, where fluid administration targets continuously-measured hemodynamic variables, such as cardiac output, stroke volume, stroke volume variation, pulse pressure variation and other factors to guide intravenous and inotropic therapy, with the aim of maximizing tissue perfusion and oxygen delivery.
Cardiac output is assessed by static indices or dynamic indices. Static indices of cardiac preload such as central venous pressure (CVP) and pulmonary artery wedge pressure are of little help for decisions regarding volume replacement. Dynamic variables such as pulse pressure variation (PPV) and stroke volume variation (SVV) are increasingly used to detect the cyclic fluctuation of the arterial pressure wave in the mechanically ventilated patient in order to predict fluid responsiveness.
Direct measurement of SV using noninvasive techniques has become an accepted tool for stroke volume optimization and guiding fluid administration in highly risk surgical patients. Many technologies are used to measure stroke volume, including Doppler monitoring, bio impedance/reactance measurements, and arterial waveform analysis. So, when stroke volume optimization is used as the end point, it could improve the outcomes for surgical patients with good prediction of fluid administration.
Impedance cardiography (ICG) is an accurate technique for noninvasive determination of hemodynamic variables such as stroke volume (SV), stroke volume index (SVI), cardiac output (COP), cardiac index (CI), systemic vascular resistance (SVR), and systolic time ratio (STR). ICG use electrical impedance changes to generate waveform that depend on volume and velocity of blood injected into aorta as well as the force and rate of left ventricle contraction. From that curve beside heart rate and blood pressure, stroke volume ,COP ,SVR and other hemodynamic parameter are derived
- Conditions
- Fluid Therapy
- Being tested
- ICON
- Keywords
- fluid therapy, goal directed , liberal , colorectal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICONDevice
hemodynamics variability in response to different fluid regiemens
| Study group | Role | What they receive |
|---|---|---|
| • Liberal fluid group (L group) using traditional technique of fluid administration | Not described Receives: Device: ICON | |
| • Goal directed fluid group(G group) using stroke volume optimization | Not described Receives: Device: ICON |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum creatinine level
mg/dl
Measured: 24 hours postoperative
Secondary outcomes (5)
stroke volume (SV)
Measured: Basal preoperative, before induction of anesthesia (T1), just before skin incision (T2), then every 30 min until end of surgery then every 6 hour for 24 hours
stroke volume variation (SVV)
percentage
Measured: Basal preoperative, before induction of anesthesia (T1), just before skin incision (T2), then every 30 min until end of surgery then every 6 hour for 24 hours
stroke volume index (SVI)
ml/m2
Measured: Basal preoperative, before induction of anesthesia (T1), just before skin incision (T2), then every 30 min until end of surgery then every 6 hour for 24 hours
cardiac index
L/minute/m2
Measured: Basal preoperative, before induction of anesthesia (T1), just before skin incision (T2), then every 30 min until end of surgery then every 6 hour for 24 hours
cardiac output (COP)
L/minute
Measured: Basal preoperative, before induction of anesthesia (T1), just before skin incision (T2), then every 30 min until end of surgery then every 6 hour for 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start10 Jan 2020
- Primary completion15 Jun 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid TherapyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Gad mostafa, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487222
- Sponsor's protocol ID
- R.19.12.704
- Status last verified
- Aug 2022
- First submitted
- 28 Dec 2021
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal Directed Fluid Therapy Compared to Liberal Fluid Therapy in Patients Subjected to Colorectal Surgery
- ClinicalTrials.gov ID
- NCT05487222
- Acronym / sponsor ID
- R.19.12.704
- Conditions
- Fluid Therapy
- Keywords
- fluid therapy, goal directed , liberal , colorectal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 4 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.
The aim is to compare intraoperative goal directed fluid therapy (GDFT) versus liberal fluid therapy in patients undergoing elective colorectal surgery by using noninvasive electrical cardiometry. This study hypothesized that GDFT is better than liberal fluid therapy to provide sufficient intra-vascular fluid volume for adequate perfusion without impairing glycolcalyx function with fluid overload
Detailed description
Intraoperative fluid management for major abdominal and intestinal surgeries is quite important in terms of postoperative organ perfusion and complications. Many complications such as acute renal failure, hypotension, arrhythmia, and anastomosis leak may occur secondary to intraoperative hypovolemia whereas hypervolemia may cause pulmonary edema, postoperative pneumonia, prolonged mechanical ventilation, delayed wound healing, edema in the gastrointestinal system (GIS), and decreased GIS motility.
In the perioperative period, fluid therapy and gastrointestinal function may complement each other or complicate it. If fluid therapy is not optimal, it may cause delayed gastrointestinal function and avoid early oral intake. If gastrointestinal dysfunction develops in the perioperative period, it may lead to fluid and electrolyte loss and metabolic problems. Thus, the intraoperative fluid management of the patient is very important.
Accurate assessment of a patient's volume status is an important goal for the anesthetist in the operating theatre to achieve hemodynamic stability and adequate tissue oxygenation. Different intraoperative fluid management protocols are in use for this purpose. The most common one is conventional fluid management (CFM). Fluid replacement is managed according to clinical assessment and heart rate (HR), arterial blood pressure (ABP) and central venous pressure (CVP) monitorization.
While goal-directed fluid therapy (GDFT) is a perioperative strategy, where fluid administration targets continuously-measured hemodynamic variables, such as cardiac output, stroke volume, stroke volume variation, pulse pressure variation and other factors to guide intravenous and inotropic therapy, with the aim of maximizing tissue perfusion and oxygen delivery.
Cardiac output is assessed by static indices or dynamic indices. Static indices of cardiac preload such as central venous pressure (CVP) and pulmonary artery wedge pressure are of little help for decisions regarding volume replacement. Dynamic variables such as pulse pressure variation (PPV) and stroke volume variation (SVV) are increasingly used to detect the cyclic fluctuation of the arterial pressure wave in the mechanically ventilated patient in order to predict fluid responsiveness.
Direct measurement of SV using noninvasive techniques has become an accepted tool for stroke volume optimization and guiding fluid administration in highly risk surgical patients. Many technologies are used to measure stroke volume, including Doppler monitoring, bio impedance/reactance measurements, and arterial waveform analysis. So, when stroke volume optimization is used as the end point, it could improve the outcomes for surgical patients with good prediction of fluid administration.
Impedance cardiography (ICG) is an accurate technique for noninvasive determination of hemodynamic variables such as stroke volume (SV), stroke volume index (SVI), cardiac output (COP), cardiac index (CI), systemic vascular resistance (SVR), and systolic time ratio (STR). ICG use electrical impedance changes to generate waveform that depend on volume and velocity of blood injected into aorta as well as the force and rate of left ventricle contraction. From that curve beside heart rate and blood pressure, stroke volume ,COP ,SVR and other hemodynamic parameter are derived
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| • Liberal fluid group (L group) using traditional technique of fluid administration | – | Device: ICON |
| • Goal directed fluid group(G group) using stroke volume optimization | – | Device: ICON |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- This prospective, randomized, controlled study was conducted after a written informed consent will be obtained from all participants
Key inclusion criteria (3 listed)
- • patients scheduled for elective colorectal surgery
Key exclusion criteria (5 listed)
- • Patient refusal
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 |
|---|---|---|
| ICONhemodynamics variability in response to different fluid regiemens | Device | • Goal directed fluid group(G group) using stroke volume optimization, • Liberal fluid group (L group) using traditional technique of fluid administration |
Primary outcome
serum creatinine level
Time frame: 24 hours postoperative
mg/dl
5 secondary outcomes
stroke volume (SV)
Time frame: Basal preoperative, before induction of anesthesia (T1), just before skin incision (T2), then every 30 min until end of surgery then every 6 hour for 24 hours
stroke volume variation (SVV)
Time frame: Basal preoperative, before induction of anesthesia (T1), just before skin incision (T2), then every 30 min until end of surgery then every 6 hour for 24 hours
stroke volume index (SVI)
Time frame: Basal preoperative, before induction of anesthesia (T1), just before skin incision (T2), then every 30 min until end of surgery then every 6 hour for 24 hours
cardiac index
Time frame: Basal preoperative, before induction of anesthesia (T1), just before skin incision (T2), then every 30 min until end of surgery then every 6 hour for 24 hours
cardiac output (COP)
Time frame: Basal preoperative, before induction of anesthesia (T1), just before skin incision (T2), then every 30 min until end of surgery then every 6 hour for 24 hours
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 4 Aug 2022.
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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?
An observational study of Fluid Therapy, run by Mansoura 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 3 inclusion and 5 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 4 Aug 2022. 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?
serum creatinine level (time frame: 24 hours postoperative). 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 4 Aug 2022.