Stroke Volume Variation-guided Fluid Infusion in Major Liver Tumour Resection
Sponsor
Kaohsiung Veterans General Hospital. (Other)
Overall Status
Completed
CT.gov ID
NCT05361252
Collaborator
(none)
118
1
2
22.9
5.1
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
118 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (Participant)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Feb 1, 2017
Actual Primary Completion Date
:
Dec 31, 2018
Actual Study Completion Date
:
Dec 31, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
fluid will be guided by value of stroke volume variation
|
| Active Comparator: the high-SVV group the value of stroke volume variation will be higher than 10 this group |
Procedure: SVV-guided fluid management
fluid will be guided by value of stroke volume variation
|
Outcome Measures
Primary Outcome Measures
- The incidence of postoperative complications in the two groups. [From day 1 to day 30 after surgery.]
calculate the incidence of postoperative complication within 30 days
Secondary Outcome Measures
- The differences of perioperative ALT [Examination report on the 1st postoperative day.]
Calculate the difference of the perioperative physiological variables
- The differences of perioperative eGFR [Examination report on the 1st postoperative day.]
Calculate the difference of the perioperative physiological variables
- The differences of perioperative creatinine [Examination report on the 1st postoperative day.]
Calculate the difference of the perioperative physiological variables
- The differences of perioperative T.bil [Examination report on the 1st postoperative day.]
Calculate the difference of the perioperative physiological variables
- The differences of perioperative Hb [Examination report on the 1st postoperative day.]
Calculate the difference of the perioperative physiological variables
- The differences of perioperative arterial lactate [Examination report on the 1st postoperative day.]
Calculate the difference of the perioperative physiological variables
- The differences of perioperative albumin [Examination report on the 1st postoperative day.]
Calculate the difference of the perioperative physiological variables
- The pain scale [up to three days postoperatively]
Assessment of postoperative pain scale
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 75 Years
Sexes Eligible for Study:
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:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaohsiung Veterans General Hospital | Kaohsiung | Taiwan | 81362 |
Sponsors and Collaborators
- Kaohsiung Veterans General Hospital.
Investigators
- Principal Investigator: Yuan-Yi Chia, Director, Kaohsiung Veterans General Hospital.
- Study Director: Kai-Wei Hsieh, physician, Kaohsiung Veterans General Hospital.
- Study Chair: We-Yu Chen, physician, Kaohsiung Veterans General Hospital.
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review. Retraction in: Intensive Care Med. 2020 Jun;46(6):1301.
- 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.
- 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. Review.
- 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.
- 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.
- Giannini EG, Testa R, Savarino V. Liver enzyme alteration: a guide for clinicians. CMAJ. 2005 Feb 1;172(3):367-79. Review.
- 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.
- 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. Retraction in: Anesth Analg. 2011 May;112(5):1211.
- Lefrant JY, Bruelle P, Aya AG, Saïssi 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.
- 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.
- 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.
- 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. Epub 2004 Jul 8. Erratum in: BMJ. 2004 Aug 21;329(7463):438.
- 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. Epub 2006 Mar 7.
- 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. Review.
- 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.
- 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.
- 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. Review.
- 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. Review.
- Saner F. Kidney failure following liver resection. Transplant Proc. 2008 May;40(4):1221-4. doi: 10.1016/j.transproceed.2008.03.068.
- Sear JW. Kidney dysfunction in the postoperative period. Br J Anaesth. 2005 Jul;95(1):20-32. Epub 2004 Nov 5. Review.
- 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. Review.
- 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.
- 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.
- 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.
- 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. Epub 2005 Sep 9.
- 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.
Responsible Party:
Yuan-Yi Chia,
Chief of Anesthesiology,
Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT05361252
Other Study ID Numbers:
- VGHKS16-CT8-25
First Posted:
May 4, 2022
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yuan-Yi Chia,
Chief of Anesthesiology,
Kaohsiung Veterans General Hospital.
Additional relevant MeSH terms: