Colon SurgeryNCT02770027
Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity for Colon Surgery
A study testing Intravenous Crystalloid and Intravenous HES in people with Colon Surgery, run by Konkuk University Medical Center.
Trial summary
After obtaining approval from the Institutional Review Board of our institution, written informed consent is obtained from patients undergoing colon surgery are enrolled in this prospective study and randomly allocated into one of two groups: Group-C (n=15) and Group-HES (n=15). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Colon Surgery
- What is being tested?
- Intravenous Crystalloid and Intravenous HES
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Dec 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing colon surgery
- Patients provided a written informed consent.
- Patients with preoperative serum hemoglobin concentration >13 g/dL (male) and >12 g/dL (female)
- Patients with PaO2/FiO2 ratio >150
Who cannot join
- Patients with history of anemia, dyspnea, active infection.
- Patients with endocrine disease
- Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-platelet drug, anti-fibrinolytic agents or recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Intravascular Fluid Resuscitation on Whole Blood Viscosity During Colon Surgery
After obtaining approval from the Institutional Review Board of our institution, written informed consent is obtained from patients undergoing colon surgery are enrolled in this prospective study and randomly allocated into one of two groups: Group-C (n=15) and Group-HES (n=15).
All recruited patients will be given patient identification number (PIN) for the present study of 01-30 according to their order of interview and recruitment. Investigators will prepare 15 yellow and 15 green cards, which will be inserted in 30 thick-paper envelopes. Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30 (Envelop number).
Read more
According to the color of the card, attending anesthesiologists will give crystalloid for yellow card or HES for green cards, respectively, to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.
Patient data and statistical analyses:
Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be determined from the patients' medical record after patient's discharge.
All statistical analyses will be performed after the 30th patient's discharge and data acquisition
- Conditions
- Colon Surgery
- Being tested
- Intravenous Crystalloid, Intravenous HES
- Keywords
- Colon Surgery, blood viscosity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous CrystalloidDrug
Crystalloid is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture
Intravenous HESDrug
HES is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Crystalloid | Placebo comparator | Crystalloid is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture Receives: Drug: Intravenous Crystalloid |
| Intravenous HES | Active comparator | HES is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture Receives: Drug: Intravenous HES |
What is being measured
The primary outcome is the main question the study is designed to answer.
whole blood viscosity
whole blood viscosity measured by viscometer cm-1
Measured: with 1 hour after the completion of procedure
Secondary outcomes (6)
PaO2/FiO2 ratio
PaO2/FiO2 ratio measured by arterial blood gas analysis
Measured: 1 hour after the completion of procedure
hematocrit
serum hematocrit, %
Measured: 1 hour after the completion of procedure
glucose
serum glucose level, g/dl
Measured: 1 hour after the completion of procedure
osmolarity
serum osmolarity, mOsm
Measured: 1 hour after the completion of procedure
urine output
hourly urine output, ml/hr
Measured: 1 hour after the completion of procedure
Maximum clot formation
Maximum clot formation in rotational thromboelastometry (ROTEM) analysis, mm
Measured: 1 hour after the completion of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startSep 2020 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon SurgeryStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770027
- Sponsor's protocol ID
- KUH000013
- Status last verified
- Jan 2020
- First submitted
- 10 May 2016
- Last updated
- 14 Jan 2020
- 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 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intravascular Fluid Resuscitation on Whole Blood Viscosity During Colon Surgery
- ClinicalTrials.gov ID
- NCT02770027
- Acronym / sponsor ID
- KUH000013
- Conditions
- Colon Surgery
- Keywords
- Colon Surgery, blood viscosity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 12 May 2016 (estimated)
- 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.
After obtaining approval from the Institutional Review Board of our institution, written informed consent is obtained from patients undergoing colon surgery are enrolled in this prospective study and randomly allocated into one of two groups: Group-C (n=15) and Group-HES (n=15).
All recruited patients will be given patient identification number (PIN) for the present study of 01-30 according to their order of interview and recruitment. Investigators will prepare 15 yellow and 15 green cards, which will be inserted in 30 thick-paper envelopes. Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30 (Envelop number).
According to the color of the card, attending anesthesiologists will give crystalloid for yellow card or HES for green cards, respectively, to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.
Patient data and statistical analyses:
Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be determined from the patients' medical record after patient's discharge.
All statistical analyses will be performed after the 30th patient's discharge and data acquisition
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Crystalloid | Placebo comparator | Drug: Intravenous CrystalloidCrystalloid is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture |
| Intravenous HES | Active comparator | Drug: Intravenous HESHES is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing colon surgery
- Patients provided a written informed consent.
- Patients with preoperative serum hemoglobin concentration >13 g/dL (male) and >12 g/dL (female)
- Patients with PaO2/FiO2 ratio >150
Key exclusion criteria (3 listed)
- Patients with history of anemia, dyspnea, active infection.
- Patients with endocrine disease
- Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-platelet drug, anti-fibrinolytic agents or recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.
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 |
|---|---|---|
| Intravenous CrystalloidCrystalloid is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture | Drug | Intravenous Crystalloid |
| Intravenous HESHES is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture | Drug | Intravenous HES |
Primary outcome
whole blood viscosity
Time frame: with 1 hour after the completion of procedure
whole blood viscosity measured by viscometer cm-1
6 secondary outcomes
PaO2/FiO2 ratio
Time frame: 1 hour after the completion of procedure
hematocrit
Time frame: 1 hour after the completion of procedure
glucose
Time frame: 1 hour after the completion of procedure
osmolarity
Time frame: 1 hour after the completion of procedure
urine output
Time frame: 1 hour after the completion of procedure
Maximum clot formation
Time frame: 1 hour after the completion of procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous Crystalloid and Intravenous HES in people with Colon Surgery, run by Konkuk University Medical Center.
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 4 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 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Tae-Yop Kim, MD, PhD (82-2-2030-5448, taeyop@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
whole blood viscosity (time frame: with 1 hour after the completion of procedure). 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 14 Jan 2020.