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CompletedNCT05361252Updated Jul 1, 2022

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

An interventional study of SVV-guided fluid management in Fluid Management, sponsored by Kaohsiung Veterans General Hospital.. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-01.

Sponsored by Kaohsiung Veterans General Hospital. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 2 months after the study started (first participant enrolled Feb 2017, registered Apr 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
118
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Fluid Management

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Keywords

  • Stroke volume variation
  • Fluid therapy
  • Hepatectomy
  • Alanine aminotransferase
  • Estimated glomerular filtration rate
03

In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's enrollment of 118 is above the median of 47 across 968 interventional studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

Kaohsiung Veterans General Hospital. is the lead sponsor of 102 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
118 participants (actual)

Study arms

  • Active comparator
    the low-SVV group

    the value of stroke volume variation will be less than or equal to 10 this group

    Procedure: SVV-guided fluid management

  • Active comparator
    the high-SVV group

    the value of stroke volume variation will be higher than 10 this group

    Procedure: SVV-guided fluid management

Interventions

  • ProcedureSVV-guided fluid management

    fluid will be guided by value of stroke volume variation

06

What researchers measure

Primary outcomes

  1. The incidence of postoperative complications in the two groups.

    calculate the incidence of postoperative complication within 30 days

    Time frame: From day 1 to day 30 after surgery.

Secondary outcomes

  1. The differences of perioperative ALT

    Calculate the difference of the perioperative physiological variables

    Time frame: Examination report on the 1st postoperative day.

  2. The differences of perioperative eGFR

    Calculate the difference of the perioperative physiological variables

    Time frame: Examination report on the 1st postoperative day.

  3. The differences of perioperative creatinine

    Calculate the difference of the perioperative physiological variables

    Time frame: Examination report on the 1st postoperative day.

  4. The differences of perioperative T.bil

    Calculate the difference of the perioperative physiological variables

    Time frame: Examination report on the 1st postoperative day.

  5. The differences of perioperative Hb

    Calculate the difference of the perioperative physiological variables

    Time frame: Examination report on the 1st postoperative day.

  6. The differences of perioperative arterial lactate

    Calculate the difference of the perioperative physiological variables

    Time frame: Examination report on the 1st postoperative day.

  7. The differences of perioperative albumin

    Calculate the difference of the perioperative physiological variables

    Time frame: Examination report on the 1st postoperative day.

  8. The pain scale

    Assessment of postoperative pain scale

    Time frame: up to three days postoperatively

07

Study locations

1 site
  • Kaohsiung Veterans General Hospital
    Kaohsiung, 81362, Taiwan
08

References and documents

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. Erratum In: BMJ. 2004 Aug 21;329(7463):438. 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 ↗
  • Lim C, Audureau E, Salloum C, Levesque E, Lahat E, Merle JC, Compagnon P, Dhonneur G, Feray C, Azoulay D. Acute kidney injury following hepatectomy for hepatocellular carcinoma: incidence, risk factors and prognostic value. HPB (Oxford). 2016 Jun;18(6):540-8. doi: 10.1016/j.hpb.2016.04.004. Epub 2016 May 7. PubMed 27317959 ↗
  • Slankamenac K, Breitenstein S, Held U, Beck-Schimmer B, Puhan MA, Clavien PA. Development and validation of a prediction score for postoperative acute renal failure following liver resection. Ann Surg. 2009 Nov;250(5):720-8. doi: 10.1097/SLA.0b013e3181bdd840. PubMed 19809295 ↗
  • Saner F. Kidney failure following liver resection. Transplant Proc. 2008 May;40(4):1221-4. doi: 10.1016/j.transproceed.2008.03.068. PubMed 18555153 ↗
  • Peres LA, Bredt LC, Cipriani RF. Acute renal injury after partial hepatectomy. World J Hepatol. 2016 Jul 28;8(21):891-901. doi: 10.4254/wjh.v8.i21.891. PubMed 27478539 ↗
  • Jarnagin WR, Gonen M, Fong Y, DeMatteo RP, Ben-Porat L, Little S, Corvera C, Weber S, Blumgart LH. Improvement in perioperative outcome after hepatic resection: analysis of 1,803 consecutive cases over the past decade. Ann Surg. 2002 Oct;236(4):397-406; discussion 406-7. doi: 10.1097/01.SLA.0000029003.66466.B3. PubMed 12368667 ↗
  • Moug SJ, Smith D, Wilson IS, Leen E, Horgan PG. The renal sequelae of a novel triphasic approach to blood loss reduction during hepatic resection. Eur J Surg Oncol. 2006 May;32(4):435-8. doi: 10.1016/j.ejso.2006.01.011. Epub 2006 Mar 7. PubMed 16520017 ↗
  • Giannini EG, Testa R, Savarino V. Liver enzyme alteration: a guide for clinicians. CMAJ. 2005 Feb 1;172(3):367-79. doi: 10.1503/cmaj.1040752. PubMed 15684121 ↗
  • Olthof PB, Huiskens J, Schulte NR, Wicherts DA, Besselink MG, Busch OR, Heger M, van Gulik TM. Postoperative peak transaminases correlate with morbidity and mortality after liver resection. HPB (Oxford). 2016 Nov;18(11):915-921. doi: 10.1016/j.hpb.2016.07.016. Epub 2016 Sep 2. PubMed 27600437 ↗
  • Siu J, McCall J, Connor S. Systematic review of pathophysiological changes following hepatic resection. HPB (Oxford). 2014 May;16(5):407-21. doi: 10.1111/hpb.12164. Epub 2013 Aug 29. PubMed 23991862 ↗
  • Yu LH, Yu WL, Zhao T, Wu MC, Fu XH, Zhang YJ. Post-operative delayed elevation of ALT correlates with early death in patients with HBV-related hepatocellular carcinoma and Post-hepatectomy Liver Failure. HPB (Oxford). 2018 Apr;20(4):321-326. doi: 10.1016/j.hpb.2017.10.001. Epub 2018 Jan 17. PubMed 29373299 ↗
  • Choi SS, Kim SH, Kim YK. Fluid management in living donor hepatectomy: Recent issues and perspectives. World J Gastroenterol. 2015 Dec 7;21(45):12757-66. doi: 10.3748/wjg.v21.i45.12757. PubMed 26668500 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05361252
Lead sponsor
Kaohsiung Veterans General Hospital.
Responsible party
Yuan-Yi Chia (Chief of Anesthesiology, Kaohsiung Veterans General Hospital.) — Principal investigator
First posted
May 4, 2022
Start date
Feb 1, 2017
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Jul 1, 2022

Study contacts

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.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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