Fluid ManagementNCT05361252

Stroke Volume Variation-guided Fluid Infusion in Major Liver Tumour Resection

A study testing SVV-guided fluid management in people with Fluid Management, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 20 to 75 years
Conditions the study is for: Fluid Management
What is being tested?: SVV-guided fluid management
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 118 participants
Where: 1 siteTaiwan
Study dates: 1 Feb 2017to 31 Dec 2018
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 20 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

We initially selected 118 patients who required hepatectomy.
The physiological status of the patients was assessed in terms of American Society of Anesthesiologists scores I-III

Who cannot join

Extreme body mass index (BMI)
Age under 20 or over 75 years
Emergency surgery
Preexisting cardiac, hepatic, renal, or coagulation disorder; hyperthyroidism; and sinus arrhythmia.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Kaohsiung Veterans General Hospital
Kaohsiung City, 81362

Other trials in Taiwan

About this study

Official title: Restrictive Versus Liberal Stroke Volume Variation-guided Fluid Infusion in Major Liver Tumour Resection: a Prospective Randomised Trial of Perioperative Quality of Care

Studies have demonstrated that the rate of change in stroke volume variation (SVV) can be used to determine the volume of body fluids during major abdominal surgery. Anaesthesiologists can use SVV as a guide for the appropriate administration of intraoperative fluids to improve postoperative prognoses. Liver surgery is a major abdominal operation, and the amount of blood lost is typically higher than that during other general abdominal surgeries. Blood loss is positively correlated with the intraoperative fluid infusion volume, and greater blood loss is associated with more postoperative complications. Additionally, comorbid liver disease or cirrhosis can increase the complexity of liver tumour resection, causing difficulty in assessing intravascular volume and determining the appropriate intraoperative infusion volume.

Conditions: Fluid Management
Being tested: SVV-guided fluid management
Keywords: Stroke volume variation, Fluid therapy, Hepatectomy, Alanine aminotransferase, Estimated glomerular filtration rate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SVV-guided fluid managementProcedure or surgery
fluid will be guided by value of stroke volume variation

Study groups in NCT05361252
Study group	Role	What they receive
the low-SVV group	Active comparator	the value of stroke volume variation will be less than or equal to 10 this group Receives: Procedure: SVV-guided fluid management
the high-SVV group	Active comparator	the value of stroke volume variation will be higher than 10 this group Receives: Procedure: SVV-guided fluid management

What is being measured

The primary outcome is the main question the study is designed to answer.

The incidence of postoperative complications in the two groups.
calculate the incidence of postoperative complication within 30 days
Measured: From day 1 to day 30 after surgery.

Secondary outcomes (8)

The differences of perioperative ALT
Calculate the difference of the perioperative physiological variables
Measured: Examination report on the 1st postoperative day.
The differences of perioperative eGFR
Calculate the difference of the perioperative physiological variables
Measured: Examination report on the 1st postoperative day.
The differences of perioperative creatinine
Calculate the difference of the perioperative physiological variables
Measured: Examination report on the 1st postoperative day.
The differences of perioperative T.bil
Calculate the difference of the perioperative physiological variables
Measured: Examination report on the 1st postoperative day.
The differences of perioperative Hb
Calculate the difference of the perioperative physiological variables
Measured: Examination report on the 1st postoperative day.
The differences of perioperative arterial lactate
Calculate the difference of the perioperative physiological variables
Measured: Examination report on the 1st postoperative day.
The differences of perioperative albumin
Calculate the difference of the perioperative physiological variables
Measured: Examination report on the 1st postoperative day.
The pain scale
Assessment of postoperative pain scale
Measured: up to three days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201731 Dec 2018

First posted4 May 2022
Study start1 Feb 2017
Primary completion31 Dec 2018
Study completion31 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (26)Papers the sponsor has linked to this study.
Other trials for Fluid ManagementStudies 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
Model description: This trial had a randomised study design with simple randomisation and a fixed allocation ratio (1:1 to the low-SVV group or high-SVV group). The patients were blinded to the randomisation and allocation.
Masking: Single blind
Who is masked: Participant
Enrolment: 118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05361252
Sponsor's protocol ID: VGHKS16-CT8-25
Status last verified: Jun 2022
First submitted: 29 Apr 2022
Last updated: 1 Jul 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lang K, Boldt J, Suttner S, Haisch G. Colloids versus crystalloids and tissue oxygen tension in patients undergoing major abdominal surgery. Anesth Analg. 2001 Aug;93(2):405-9 , 3rd contents page. doi: 10.1097/00000539-200108000-00034.
PubMed 11473870
Mythen MG, Webb AR. The role of gut mucosal hypoperfusion in the pathogenesis of post-operative organ dysfunction. Intensive Care Med. 1994;20(3):203-9. doi: 10.1007/BF01704701. No abstract available.
PubMed 8014287
Sear JW. Kidney dysfunction in the postoperative period. Br J Anaesth. 2005 Jul;95(1):20-32. doi: 10.1093/bja/aei018. Epub 2004 Nov 5.
PubMed 15531622
Osman D, Ridel C, Ray P, Monnet X, Anguel N, Richard C, Teboul JL. Cardiac filling pressures are not appropriate to predict hemodynamic response to volume challenge. Crit Care Med. 2007 Jan;35(1):64-8. doi: 10.1097/01.CCM.0000249851.94101.4F.
PubMed 17080001
Tavernier B, Makhotine O, Lebuffe G, Dupont J, Scherpereel P. Systolic pressure variation as a guide to fluid therapy in patients with sepsis-induced hypotension. Anesthesiology. 1998 Dec;89(6):1313-21. doi: 10.1097/00000542-199812000-00007.
PubMed 9856704
Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.
PubMed 12357146
Su NY, Huang CJ, Tsai P, Hsu YW, Hung YC, Cheng CR. Cardiac output measurement during cardiac surgery: esophageal Doppler versus pulmonary artery catheter. Acta Anaesthesiol Sin. 2002 Sep;40(3):127-33.
PubMed 12434609
Wakeling HG, McFall MR, Jenkins CS, Woods WG, Miles WF, Barclay GR, Fleming SC. Intraoperative oesophageal Doppler guided fluid management shortens postoperative hospital stay after major bowel surgery. Br J Anaesth. 2005 Nov;95(5):634-42. doi: 10.1093/bja/aei223. Epub 2005 Sep 9.
PubMed 16155038
Lefrant JY, Bruelle P, Aya AG, Saissi G, Dauzat M, de La Coussaye JE, Eledjam JJ. Training is required to improve the reliability of esophageal Doppler to measure cardiac output in critically ill patients. Intensive Care Med. 1998 Apr;24(4):347-52. doi: 10.1007/s001340050578.
PubMed 9609413
Lopes MR, Oliveira MA, Pereira VO, Lemos IP, Auler JO Jr, Michard F. Goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery: a pilot randomized controlled trial. Crit Care. 2007;11(5):R100. doi: 10.1186/cc6117.
PubMed 17822565
McKendry M, McGloin H, Saberi D, Caudwell L, Brady AR, Singer M. Randomised controlled trial assessing the impact of a nurse delivered, flow monitored protocol for optimisation of circulatory status after cardiac surgery. BMJ. 2004 Jul 31;329(7460):258. doi: 10.1136/bmj.38156.767118.7C. Epub 2004 Jul 8.
PubMed 15242867
Boldt J, Ince C. The impact of fluid therapy on microcirculation and tissue oxygenation in hypovolemic patients: a review. Intensive Care Med. 2010 Aug;36(8):1299-308. doi: 10.1007/s00134-010-1912-7. Epub 2010 May 26.
PubMed 20502873
Rahbari NN, Zimmermann JB, Schmidt T, Koch M, Weigand MA, Weitz J. Meta-analysis of standard, restrictive and supplemental fluid administration in colorectal surgery. Br J Surg. 2009 Apr;96(4):331-41. doi: 10.1002/bjs.6552.
PubMed 19283742
Choi JM, Lee YK, Yoo H, Lee S, Kim HY, Kim YK. Relationship between Stroke Volume Variation and Blood Transfusion during Liver Transplantation. Int J Med Sci. 2016 Feb 20;13(3):235-9. doi: 10.7150/ijms.14188. eCollection 2016.
PubMed 26941584
Correa-Gallego C, Tan KS, Arslan-Carlon V, Gonen M, Denis SC, Langdon-Embry L, Grant F, Kingham TP, DeMatteo RP, Allen PJ, D'Angelica MI, Jarnagin WR, Fischer M. Goal-Directed Fluid Therapy Using Stroke Volume Variation for Resuscitation after Low Central Venous Pressure-Assisted Liver Resection: A Randomized Clinical Trial. J Am Coll Surg. 2015 Aug;221(2):591-601. doi: 10.1016/j.jamcollsurg.2015.03.050. Epub 2015 Apr 7.
PubMed 26206652

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
Not yet recruiting
ASSISTED FLUID MANAGEMENT SYSTEM IN KIDENY TRANSPLANTATION
Kidney Transplant
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function

All Fluid Management trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Restrictive Versus Liberal Stroke Volume Variation-guided Fluid Infusion in Major Liver Tumour Resection: a Prospective Randomised Trial of Perioperative Quality of Care
ClinicalTrials.gov ID: NCT05361252
Acronym / sponsor ID: VGHKS16-CT8-25
Conditions: Fluid Management
Keywords: Stroke volume variation, Fluid therapy, Hepatectomy, Alanine aminotransferase, Estimated glomerular filtration rate
Study type: Interventional
Recruitment status: Completed
Enrolment: 118 participants (actual)
Lead sponsor: Kaohsiung Veterans General Hospital.University, hospital or other
Study start: 1 Feb 2017 (actual)
Primary completion: 31 Dec 2018 (actual)
Study completion: 31 Dec 2018 (actual)
First posted: 4 May 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: This trial had a randomised study design with simple randomisation and a fixed allocation ratio (1:1 to the low-SVV group or high-SVV group). The patients were blinded to the randomisation and allocation.

Arm	Type	Receives
the low-SVV group	Active comparator	Procedure: SVV-guided fluid managementthe value of stroke volume variation will be less than or equal to 10 this group
the high-SVV group	Active comparator	Procedure: SVV-guided fluid managementthe value of stroke volume variation will be higher than 10 this group

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

We initially selected 118 patients who required hepatectomy.
The physiological status of the patients was assessed in terms of American Society of Anesthesiologists scores I-III

Key exclusion criteria (4 listed)

Extreme body mass index (BMI)
Age under 20 or over 75 years
Emergency surgery
Preexisting cardiac, hepatic, renal, or coagulation disorder; hyperthyroidism; and sinus arrhythmia.

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
SVV-guided fluid managementfluid will be guided by value of stroke volume variation	Procedure or surgery	the high-SVV group, the low-SVV group

Primary outcome

The incidence of postoperative complications in the two groups.
Time frame: From day 1 to day 30 after surgery.
calculate the incidence of postoperative complication within 30 days

8 secondary outcomes

The differences of perioperative ALT
Time frame: Examination report on the 1st postoperative day.
The differences of perioperative eGFR
Time frame: Examination report on the 1st postoperative day.
The differences of perioperative creatinine
Time frame: Examination report on the 1st postoperative day.
The differences of perioperative T.bil
Time frame: Examination report on the 1st postoperative day.
The differences of perioperative Hb
Time frame: Examination report on the 1st postoperative day.
The differences of perioperative arterial lactate
Time frame: Examination report on the 1st postoperative day.
The differences of perioperative albumin
Time frame: Examination report on the 1st postoperative day.
The pain scale
Time frame: up to three days postoperatively

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 1 Jul 2022.
Background: PubMed 11473870Lang K, Boldt J, Suttner S, Haisch G. Colloids versus crystalloids and tissue oxygen tension in patients undergoing major abdominal surgery. Anesth Analg. 2001 Aug;93(2):405-9 , 3rd contents page. doi: 10.1097/00000539-200108000-00034.
Background: PubMed 8014287Mythen MG, Webb AR. The role of gut mucosal hypoperfusion in the pathogenesis of post-operative organ dysfunction. Intensive Care Med. 1994;20(3):203-9. doi: 10.1007/BF01704701. No abstract available.
Background: PubMed 15531622Sear JW. Kidney dysfunction in the postoperative period. Br J Anaesth. 2005 Jul;95(1):20-32. doi: 10.1093/bja/aei018. Epub 2004 Nov 5.
Background: PubMed 17080001Osman D, Ridel C, Ray P, Monnet X, Anguel N, Richard C, Teboul JL. Cardiac filling pressures are not appropriate to predict hemodynamic response to volume challenge. Crit Care Med. 2007 Jan;35(1):64-8. doi: 10.1097/01.CCM.0000249851.94101.4F.
Background: PubMed 9856704Tavernier B, Makhotine O, Lebuffe G, Dupont J, Scherpereel P. Systolic pressure variation as a guide to fluid therapy in patients with sepsis-induced hypotension. Anesthesiology. 1998 Dec;89(6):1313-21. doi: 10.1097/00000542-199812000-00007.
Background: PubMed 12357146Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.
Background: PubMed 12434609Su NY, Huang CJ, Tsai P, Hsu YW, Hung YC, Cheng CR. Cardiac output measurement during cardiac surgery: esophageal Doppler versus pulmonary artery catheter. Acta Anaesthesiol Sin. 2002 Sep;40(3):127-33.
Background: PubMed 16155038Wakeling HG, McFall MR, Jenkins CS, Woods WG, Miles WF, Barclay GR, Fleming SC. Intraoperative oesophageal Doppler guided fluid management shortens postoperative hospital stay after major bowel surgery. Br J Anaesth. 2005 Nov;95(5):634-42. doi: 10.1093/bja/aei223. Epub 2005 Sep 9.
Background: PubMed 9609413Lefrant JY, Bruelle P, Aya AG, Saissi G, Dauzat M, de La Coussaye JE, Eledjam JJ. Training is required to improve the reliability of esophageal Doppler to measure cardiac output in critically ill patients. Intensive Care Med. 1998 Apr;24(4):347-52. doi: 10.1007/s001340050578.
Background: PubMed 17822565Lopes MR, Oliveira MA, Pereira VO, Lemos IP, Auler JO Jr, Michard F. Goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery: a pilot randomized controlled trial. Crit Care. 2007;11(5):R100. doi: 10.1186/cc6117.
Background: PubMed 15242867McKendry M, McGloin H, Saberi D, Caudwell L, Brady AR, Singer M. Randomised controlled trial assessing the impact of a nurse delivered, flow monitored protocol for optimisation of circulatory status after cardiac surgery. BMJ. 2004 Jul 31;329(7460):258. doi: 10.1136/bmj.38156.767118.7C. Epub 2004 Jul 8.
Background: PubMed 20502873Boldt J, Ince C. The impact of fluid therapy on microcirculation and tissue oxygenation in hypovolemic patients: a review. Intensive Care Med. 2010 Aug;36(8):1299-308. doi: 10.1007/s00134-010-1912-7. Epub 2010 May 26.
Individual participant dataSharing planned: No

Related trials for Fluid Management

Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
Not yet recruiting
ASSISTED FLUID MANAGEMENT SYSTEM IN KIDENY TRANSPLANTATION
Kidney Transplant
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function

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.

Yuan-Yi Chia, Director principal investigator

Kaohsiung Veterans General Hospital.

Kai-Wei Hsieh, physician study director

Kaohsiung Veterans General Hospital.

We-Yu Chen, physician study chair

Kaohsiung Veterans General Hospital.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SVV-guided fluid management in people with Fluid Management, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

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 1 Jul 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 Taiwan. 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?

The incidence of postoperative complications in the two groups. (time frame: From day 1 to day 30 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 NCT05361252, which also lists 26 linked publications.

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 1 Jul 2022.