Burn SurgeryNCT03590873
The Effect of Restrictive Fluid and Vasopressin During Surgery of Burn Patients
A study testing Vasopressin in people with Burn Surgery, run by Hangang Sacred Heart Hospital at 1 site in South Korea.
Trial summary
This is a randomized double-blinded study to investigate in which the groups are designated as the control group and the restrictive group to further evaluate significant differences in intraoperative blood loos during burn surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Surgery
- What is being tested?
- Vasopressin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jul 2018to 4 Jun 2019
- 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
- age ≥ 18 years old
- burn patients undergoing surgery (TBSA > 20%)
Who cannot join
- age < 18 years old
- history of renal disorder
- history of cardiac disorder
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hangang Sacred Heart Hospital
Seoul, 07247
Hee Yeong Kim, MD
About this study
Official title: The Effect of Restrictive Fluid and Vasopressin During Surgery of Burn Patients: a Randomized Clinical Trial
This is a randomized double-blinded study to investigate in which the groups are designated as the control group and the restrictive group to further evaluate significant differences in intraoperative blood loos during burn surgery.
Read the detailed description
This is a randomized double-blinded study to investigate the effect of fluid restriction and vasopressin on blood loss during surgery of the burn patients. The groups are designated as the control group and the restrictive group to further evaluate significant differences in intraoperative blood loss during the surgery.
- Conditions
- Burn Surgery
- Being tested
- Vasopressin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasopressinDrug
Also called Antidiuretic hormone, arginine vasopressin, or argipressin
Vasopressin, is a hormone synthesized as a peptide prohormone in neurons in the hypothalamus, and is converted to arginine vasopressin. It then travels down the axon of that cell, which terminates in the posterior pituitary, and is released from vesicles into the circulation in response to extracellular fluid hypertonicity (hyperosmolality). Arginine vasopressin has two primary functions. First, it increases the amount of solute-free water reabsorbed back into the circulation from the filtrate in the kidney tubules of the nephrons. Second, arginine vasopressin constricts arterioles, which increases peripheral vascular resistance and raises arterial blood pressure.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Intraoperative fluid management: administration of 6-10 ml/kg/hr of crystalloid solution. |
| Restrictive group | Experimental | Intervention: administration of vasopressin 0.01 - 0.04 U/min after induction of anesthesia.
Intraoperative fluid management: administration of 2-4 ml/kg/hr of crystalloid solution. Receives: Drug: Vasopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
Comparison of the amounts of estimated blood loss in the two groups.
Measured: At the end of the surgery, approximately 3 hrs
Secondary outcomes (4)
Intraoperative red blood cell transfusion
Comparison of total units of red blood cell transfusion in the two groups.
Measured: At the end of the surgery, approximately 3 hrs
Postoperative pulmonary complication
Comparison of postoperative pulmonary complication in the two groups.
Measured: Within 7 postoperative days
Postoperative cardiovascular complication
Comparison of postoperative cardiovascular complication in the two groups.
Measured: Within 7 postoperative days
Postoperative renal complication
Comparison of postoperative acute kidney injury in the two groups.
Measured: Within 7 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start25 Jul 2018
- Primary completion4 Jun 2019 (estimated)
- Study completion4 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangang Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center
- Responsible party
- Principal investigator, Hee Yeong Kim, Hangang Sacred Heart Hospital
- Investigators
- Young-Kug Kim, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590873
- Sponsor's protocol ID
- 2018-051
- Status last verified
- Jul 2018
- First submitted
- 28 Jun 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Restrictive Fluid and Vasopressin During Surgery of Burn Patients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03590873
- Acronym / sponsor ID
- 2018-051
- Conditions
- Burn Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Hangang Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- Asan Medical Center
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 4 Jun 2019 (estimated)
- Study completion
- 4 Jun 2019 (estimated)
- First posted
- 18 Jul 2018 (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.
This is a randomized double-blinded study to investigate in which the groups are designated as the control group and the restrictive group to further evaluate significant differences in intraoperative blood loos during burn surgery.
Detailed description
This is a randomized double-blinded study to investigate the effect of fluid restriction and vasopressin on blood loss during surgery of the burn patients. The groups are designated as the control group and the restrictive group to further evaluate significant differences in intraoperative blood loss during the surgery.
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 |
|---|---|---|
| Control group | No intervention | –Intraoperative fluid management: administration of 6-10 ml/kg/hr of crystalloid solution. |
| Restrictive group | Experimental | Drug: VasopressinIntervention: administration of vasopressin 0.01 - 0.04 U/min after induction of anesthesia. Intraoperative fluid management: administration of 2-4 ml/kg/hr of crystalloid solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥ 18 years old
- burn patients undergoing surgery (TBSA > 20%)
Key exclusion criteria (3 listed)
- age < 18 years old
- history of renal disorder
- history of cardiac disorder
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 |
|---|---|---|
| VasopressinAlso: Antidiuretic hormone, arginine vasopressin, or argipressinVasopressin, is a hormone synthesized as a peptide prohormone in neurons in the hypothalamus, and is converted to arginine vasopressin. It then travels down the axon of that cell, which terminates in the posterior pituitary, and is released from vesicles into the circulation in response to extracellular fluid hypertonicity (hyperosmolality). Arginine vasopressin has two primary functions. First, it increases the amount of solute-free water reabsorbed back into the circulation from the filtrate in the kidney tubules of the nephrons. Second, arginine vasopressin constricts arterioles, which increases peripheral vascular resistance and raises arterial blood pressure. | Drug | Restrictive group |
Primary outcome
Intraoperative blood loss
Time frame: At the end of the surgery, approximately 3 hrs
Comparison of the amounts of estimated blood loss in the two groups.
4 secondary outcomes
Intraoperative red blood cell transfusion
Time frame: At the end of the surgery, approximately 3 hrs
Postoperative pulmonary complication
Time frame: Within 7 postoperative days
Postoperative cardiovascular complication
Time frame: Within 7 postoperative days
Postoperative renal complication
Time frame: Within 7 postoperative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
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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.
Young-Kug Kim, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vasopressin in people with Burn Surgery, run by Hangang Sacred Heart 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 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 31 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee Yeong Kim, MD (82226395650, kimhy@hallym.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss (time frame: At the end of the surgery, approximately 3 hrs). 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 31 Jul 2018.