Fluid OverloadNCT06097923
Implementation of Fluid Strategies Using Real-time Bioelectrical Analyzer in Surgical Intensive Care Unit (SICU)
A study testing Active fluid management with BIA monitoring and Conventional fluid management without BIA monitoring in people with Fluid Overload and Fluid Loss, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
Precise assessment of postoperative volume status is important to administrate optimal fluid management. Bioelectrical impedance analysis (BIA) which measures the body composition using electric character. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Overload, Fluid Loss
- What is being tested?
- Active fluid management with BIA monitoring and Conventional fluid management without BIA monitoring
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Nov 2021to 31 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the surgical ICU after surgery under general anesthesia regardless of the type of surgery
- Patients who showed abnormal range of baseline ECW ratio by BIA (less than 0.390 or more than 0.405) that measured at the time of ICU admission
Who cannot join
- aged under 18 years
- underwent surgery under local or regional anesthesia
- pregnant
- had bone fixation or underwent limb amputation
- had any prosthetic medical devices such as pacemaker or metallic intravascular device
- stayed in ICU for less than 48 hours
Show all 10Show fewer
- readmitted within 48 hours after ICU discharge
- diagnosed with renal failure and receiving renal replacement therapy
- underwent extracorporeal membrane oxygenation treatment before surgery
- agreed for do-not-resuscitate
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Trauma and Surgical Critical Care, Department of Surgery, Seoul St. Mary's Hospital
Seoul, Seocho-gu, Banpo-dong Banpodaero 222, 137-701
About this study
Official title: Implementation of Fluid Strategies Using Real-time Bioelectrical Analyzer of Postoperative Patients in Surgical Intensive Care Unit (SICU); a Novel Guidance to Set an Ideal Fluid Status of Patient in Acute Postoperative Phase
Precise assessment of postoperative volume status is important to administrate optimal fluid management. Bioelectrical impedance analysis (BIA) which measures the body composition using electric character. Extracellular water (ECW) ratio by BIA represented as the ratio of ECW to total body water (TBW) and is known to reflect the hydration status. Based on this, we aimed to determine whether aggressive fluid control using ECW ratio could improve clinical outcomes through a single blind, randomized controlled trial.
Read the detailed description
Critically ill patients admitted to an intensive care unit (ICU) after surgery have commonly experienced a large amount of wide organ injury and profuse bleeding resulting in vessel damage during surgery. Severe systemic inflammatory reactions and pathophysiological stress could consequently occur in these patients. For patients in an acute postoperative phase, it is important to maintain organ perfusion by correcting hemodynamic instability through fluid resuscitation.
Bioelectrical impedance analysis (BIA), a non-invasive method, is useful for quantitatively measuring body composition such as body fat and muscle mass. It is also useful for evaluating volume status based on resistance and reactance of cells known to have different electrical conductivity according to biological characteristics of body composition. In our previous study using BIA, the results showed that changes in ECW ratio after surgery were related to conventional parameters of overhydrated status such as daily fluid balance or capillary leak index (CLI). In addition, overhydration with value of ECW ratio above 0.390 on 3rd postoperative day appeared to be a risk factor for postoperative morbidity and mortality.
Herein, we aim to set the ECW ratio as a guideline for postoperative volume status and confirm a hypothesis that active intervention with fluid management to control the ECW ratio by BIA could lower clinical outcomes in patients with fluid imbalance through a prospective randomized controlled study.
- Conditions
- Fluid Overload, Fluid Loss
- Being tested
- Active fluid management with BIA monitoring, Conventional fluid management without BIA monitoring
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active fluid management with BIA monitoringDrug
The participants in active fluid management with BIA monitoring arm received fluid supplementation targeting specific range of ECW ratio by BIA (0.390-0.406). If a patient with dehydrated status indicated by the ECW ratio was less than 0.390, a bolus infusion was performed using 250ml of crystalloid fluid (PlasmaLyte). If a patient with overhydrated status indicated by the ECW ratio was more than 0.406, 10mg of furosemide was administered. Changes in the ECW ratio were measured at one hour after initial intervention for fluid adjustment, and these processes continued until the ECW ratio was within the normal range (0.390-0.406).
Conventional fluid management without BIA monitoringDrug
The participants in conventional fluid management without BIA monitoring arm underwent conventional fluid management without specific targets of ECW ratio by BIA.
| Study group | Role | What they receive |
|---|---|---|
| Active fluid management with BIA monitoring | Experimental | For assessment of fluid status, a commercial portable BIA device (InBody M20®, InBody Corp., Seoul, Korea) was measured. Baseline BIA data were collected at the time of ICU admission, and BIA measurements were performed daily for 3days for all participants. The participants in active fluid management with BIA monitoring arm received fluid supplementation targeting specific range of ECW ratio by BIA (0.390-0.406). If a patient with dehydrated status indicated by the ECW ratio was less than 0.390, a bolus infusion was performed using 250ml of crystalloid fluid (PlasmaLyte). If a patient with overhydrated status indicated by the ECW ratio was more than 0.406, 10mg of furosemide was administered. Changes in the ECW ratio were measured at one hour after initial intervention for fluid adjustment, and the investigators determined whether additional intervention was needed according to results of changes. These processes continued until the ECW ratio was within the normal range (0.390-0.406). Receives: Drug: Active fluid management with BIA monitoring |
| Conventional fluid management without BIA monitoring | Experimental | For assessment of fluid status, a commercial portable BIA device with 5-kilohertz, 50-kilohertz, and 250-kilohertz alternating current (InBody M20®, InBody Corp., Seoul, Korea) was measured. Baseline BIA data were collected at the time of ICU admission. Thereafter, BIA measurements were performed daily for 3 days for all participants.
The participants in conventional fluid management without BIA monitoring arm underwent conventional fluid management without specific targets of ECW ratio by BIA. Receives: Drug: Conventional fluid management without BIA monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality rate
Proportion of patients who died during the hospitalization period among participants
Measured: Participants were followed upto 28th day after surgery
Secondary outcomes (2)
Incidence of postoperative morbidities
Proportion of patients who experienced postoperative complications among participants
Measured: Participants were followed upto 28th day after surgery
28-day mortality rate
Proportion of patients who died within 28 days after surgery among participants
Measured: Participants were followed upto 28th day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start30 Nov 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fluid OverloadStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Young Kim, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097923
- Sponsor's protocol ID
- BIA_03
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chung YJ, Lee GR, Kim HS, Kim EY. Effect of rigorous fluid management using monitoring of ECW ratio by bioelectrical impedance analysis in critically ill postoperative patients: A prospective, single-blind, randomized controlled study. Clin Nutr. 2024 Sep;43(9):2164-2176. doi: 10.1016/j.clnu.2024.07.040. Epub 2024 Jul 31.
PubMed 39142110
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Fluid Strategies Using Real-time Bioelectrical Analyzer of Postoperative Patients in Surgical Intensive Care Unit (SICU); a Novel Guidance to Set an Ideal Fluid Status of Patient in Acute Postoperative Phase
- ClinicalTrials.gov ID
- NCT06097923
- Acronym / sponsor ID
- BIA_03
- Conditions
- Fluid Overload, Fluid Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 24 Oct 2023 (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.
Precise assessment of postoperative volume status is important to administrate optimal fluid management. Bioelectrical impedance analysis (BIA) which measures the body composition using electric character. Extracellular water (ECW) ratio by BIA represented as the ratio of ECW to total body water (TBW) and is known to reflect the hydration status. Based on this, we aimed to determine whether aggressive fluid control using ECW ratio could improve clinical outcomes through a single blind, randomized controlled trial.
Detailed description
Critically ill patients admitted to an intensive care unit (ICU) after surgery have commonly experienced a large amount of wide organ injury and profuse bleeding resulting in vessel damage during surgery. Severe systemic inflammatory reactions and pathophysiological stress could consequently occur in these patients. For patients in an acute postoperative phase, it is important to maintain organ perfusion by correcting hemodynamic instability through fluid resuscitation.
Bioelectrical impedance analysis (BIA), a non-invasive method, is useful for quantitatively measuring body composition such as body fat and muscle mass. It is also useful for evaluating volume status based on resistance and reactance of cells known to have different electrical conductivity according to biological characteristics of body composition. In our previous study using BIA, the results showed that changes in ECW ratio after surgery were related to conventional parameters of overhydrated status such as daily fluid balance or capillary leak index (CLI). In addition, overhydration with value of ECW ratio above 0.390 on 3rd postoperative day appeared to be a risk factor for postoperative morbidity and mortality.
Herein, we aim to set the ECW ratio as a guideline for postoperative volume status and confirm a hypothesis that active intervention with fluid management to control the ECW ratio by BIA could lower clinical outcomes in patients with fluid imbalance through a prospective randomized controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active fluid management with BIA monitoring | Experimental | Drug: Active fluid management with BIA monitoringFor assessment of fluid status, a commercial portable BIA device (InBody M20®, InBody Corp., Seoul, Korea) was measured. Baseline BIA data were collected at the time of ICU admission, and BIA measurements were performed daily for 3days for all participants. The participants in active fluid management with BIA monitoring arm received fluid supplementation targeting specific range of ECW ratio by BIA (0.390-0.406). If a patient with dehydrated status indicated by the ECW ratio was less than 0.390, a bolus infusion was performed using 250ml of crystalloid fluid (PlasmaLyte). If a patient with overhydrated status indicated by the ECW ratio was more than 0.406, 10mg of furosemide was administered. Changes in the ECW ratio were measured at one hour after initial intervention for fluid adjustment, and the investigators determined whether additional intervention was needed according to results of changes. These processes continued until the ECW ratio was within the normal range (0.390-0.406). |
| Conventional fluid management without BIA monitoring | Experimental | Drug: Conventional fluid management without BIA monitoringFor assessment of fluid status, a commercial portable BIA device with 5-kilohertz, 50-kilohertz, and 250-kilohertz alternating current (InBody M20®, InBody Corp., Seoul, Korea) was measured. Baseline BIA data were collected at the time of ICU admission. Thereafter, BIA measurements were performed daily for 3 days for all participants. The participants in conventional fluid management without BIA monitoring arm underwent conventional fluid management without specific targets of ECW ratio by BIA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients admitted to the surgical ICU after surgery under general anesthesia regardless of the type of surgery
- Patients who showed abnormal range of baseline ECW ratio by BIA (less than 0.390 or more than 0.405) that measured at the time of ICU admission
Key exclusion criteria (10 listed)
- aged under 18 years
- underwent surgery under local or regional anesthesia
- pregnant
- had bone fixation or underwent limb amputation
- had any prosthetic medical devices such as pacemaker or metallic intravascular device
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 |
|---|---|---|
| Active fluid management with BIA monitoringThe participants in active fluid management with BIA monitoring arm received fluid supplementation targeting specific range of ECW ratio by BIA (0.390-0.406). If a patient with dehydrated status indicated by the ECW ratio was less than 0.390, a bolus infusion was performed using 250ml of crystalloid fluid (PlasmaLyte). If a patient with overhydrated status indicated by the ECW ratio was more than 0.406, 10mg of furosemide was administered. Changes in the ECW ratio were measured at one hour after initial intervention for fluid adjustment, and these processes continued until the ECW ratio was within the normal range (0.390-0.406). | Drug | Active fluid management with BIA monitoring |
| Conventional fluid management without BIA monitoringThe participants in conventional fluid management without BIA monitoring arm underwent conventional fluid management without specific targets of ECW ratio by BIA. | Drug | Conventional fluid management without BIA monitoring |
Primary outcome
In-hospital mortality rate
Time frame: Participants were followed upto 28th day after surgery
Proportion of patients who died during the hospitalization period among participants
2 secondary outcomes
Incidence of postoperative morbidities
Time frame: Participants were followed upto 28th day after surgery
28-day mortality rate
Time frame: Participants were followed upto 28th day after surgery
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 24 Oct 2023.
- Derived from this study: PubMed 39142110Chung YJ, Lee GR, Kim HS, Kim EY. Effect of rigorous fluid management using monitoring of ECW ratio by bioelectrical impedance analysis in critically ill postoperative patients: A prospective, single-blind, randomized controlled study. Clin Nutr. 2024 Sep;43(9):2164-2176. doi: 10.1016/j.clnu.2024.07.040. Epub 2024 Jul 31.
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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 Active fluid management with BIA monitoring and Conventional fluid management without BIA monitoring in people with Fluid Overload and Fluid Loss, run by Seoul St. Mary's Hospital at 1 site in South Korea.
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 10 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 24 Oct 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 South Korea. 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?
In-hospital mortality rate (time frame: Participants were followed upto 28th day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06097923, which also lists 1 linked publication.
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 24 Oct 2023.