Intrarenal Venous Flow Change During Fluid Removal in Critically Ill Patients: A Prospective Exploratory Study

NCT06216119 | Completed

• 1 other identifier: SI929/2023
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to study intrarenal venous flow patterns change, VExUS score change, and LUS score change during fluid removal treatment in critically ill patients

Conditions

Critical Illness; Fluid Overload

Keywords

critical illness; intrarenal venous flow pattern; fluid removal; venous excess ultrasound score; Renal Doppler ultrasonography; lung ultrasound

Outcome Measures

Primary Outcomes (1)

• intrarenal venous flow patterns change during fluid removal treatment in critically ill patients.

  intrarenal venous flow patterns change measured by ultrasonography

  72 hours after Fluid removal therapy

Secondary Outcomes (1)

• VExUS score change following fluid removal treatment in critically ill patients.

  72 hours after Fluid removal therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18 years old or older who will be admitted to the medical intensive care unit and require fluid removal therapy

You may qualify if:

• Adult patients aged 18 years old or older who will be admitted to the medical intensive care unit
• Expected to be hospitalized in the intensive care unit for more than 120 hours.
• The patient has stable vital signs without the need for vasoactive medications or rapid fluid resuscitation (at least 500 milliliters of colloid or 1000 milliliters of crystalloid via rapid intravenous infusion) for a minimum consecutive period of 12 hours. This includes cases where the patient receives norepinephrine at a rate not exceeding 0.1 micrograms per kilogram per minute and dobutamine at a rate not exceeding 10 micrograms per kilogram per minute, or when the patient can maintain a continuous reduction in vasoactive medications for a minimum consecutive period of 12 hours.
• The patient does not exhibit signs suggestive of inadequate organ perfusion, such as mottling skin, a capillary refill time of more than 2 seconds when nailbeds are pressed and released, or cold extremities.
• The patients require fluid removal through decisions made by attending staff or clinical guidelines, which may involve the administration of diuretics or Renal Replacement Therapy.

You may not qualify if:

• Underlying chronic kidney disease (eGFR\< 30) before enrollment
• Chronic renal replacement therapy (RRT) before enrollment such as on intermittent hemodialysis, peritoneal dialysis
• Decompensated cirrhosis with portal hypertension
• Inferior vena cava, portal vein, hepatic, renal vein thrombosis
• Ureteral obstruction
• Intraabdominal hypertension (Intraabdominal pressure \> 12 mmHg)
• Previous allergic or anaphylactic to diuretic
• Pregnant women
• Transplanted kidney, transplanted liver
• Patients with do-not-resuscitate (DNR) orders or decisions to withhold life-sustaining treatments
• Patients or their legally authorized representatives (LAR), who decline participation in the study or are unable to provide informed consent before enrollment

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (17)

• Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.

  PMID: 34599691 BACKGROUND

• Hoste EA, Maitland K, Brudney CS, Mehta R, Vincent JL, Yates D, Kellum JA, Mythen MG, Shaw AD; ADQI XII Investigators Group. Four phases of intravenous fluid therapy: a conceptual model. Br J Anaesth. 2014 Nov;113(5):740-7. doi: 10.1093/bja/aeu300. Epub 2014 Sep 9.

  PMID: 25204700 BACKGROUND

• Zhang L, Chen Z, Diao Y, Yang Y, Fu P. Associations of fluid overload with mortality and kidney recovery in patients with acute kidney injury: A systematic review and meta-analysis. J Crit Care. 2015 Aug;30(4):860.e7-13. doi: 10.1016/j.jcrc.2015.03.025. Epub 2015 Apr 9.

  PMID: 25979272 BACKGROUND

• Vaara ST, Pettila V, Kaukonen KM, Bendel S, Korhonen AM, Bellomo R, Reinikainen M; Finnish Acute Kidney Injury Study Group. The attributable mortality of acute kidney injury: a sequentially matched analysis*. Crit Care Med. 2014 Apr;42(4):878-85. doi: 10.1097/CCM.0000000000000045.

  PMID: 24201174 BACKGROUND

• Stevenson LW, Perloff JK. The limited reliability of physical signs for estimating hemodynamics in chronic heart failure. JAMA. 1989 Feb 10;261(6):884-8.

  PMID: 2913385 BACKGROUND

• Claure-Del Granado R, Mehta RL. Fluid overload in the ICU: evaluation and management. BMC Nephrol. 2016 Aug 2;17(1):109. doi: 10.1186/s12882-016-0323-6.

  PMID: 27484681 BACKGROUND

• Malbrain MLNG, Van Regenmortel N, Saugel B, De Tavernier B, Van Gaal PJ, Joannes-Boyau O, Teboul JL, Rice TW, Mythen M, Monnet X. Principles of fluid management and stewardship in septic shock: it is time to consider the four D's and the four phases of fluid therapy. Ann Intensive Care. 2018 May 22;8(1):66. doi: 10.1186/s13613-018-0402-x.

  PMID: 29789983 BACKGROUND

• Koratala A, Ronco C, Kazory A. Diagnosis of Fluid Overload: From Conventional to Contemporary Concepts. Cardiorenal Med. 2022;12(4):141-154. doi: 10.1159/000526902. Epub 2022 Sep 12.

  PMID: 36096121 BACKGROUND

• Beaubien-Souligny W, Rola P, Haycock K, Bouchard J, Lamarche Y, Spiegel R, Denault AY. Quantifying systemic congestion with Point-Of-Care ultrasound: development of the venous excess ultrasound grading system. Ultrasound J. 2020 Apr 9;12(1):16. doi: 10.1186/s13089-020-00163-w.

  PMID: 32270297 BACKGROUND

• Iida N, Seo Y, Sai S, Machino-Ohtsuka T, Yamamoto M, Ishizu T, Kawakami Y, Aonuma K. Clinical Implications of Intrarenal Hemodynamic Evaluation by Doppler Ultrasonography in Heart Failure. JACC Heart Fail. 2016 Aug;4(8):674-82. doi: 10.1016/j.jchf.2016.03.016. Epub 2016 May 11.

  PMID: 27179835 BACKGROUND

• Yamamoto M, Seo Y, Iida N, Ishizu T, Yamada Y, Nakatsukasa T, Nakagawa D, Kawamatsu N, Sato K, Machino-Ohtsuka T, Aonuma K, Ohte N, Ieda M. Prognostic Impact of Changes in Intrarenal Venous Flow Pattern in Patients With Heart Failure. J Card Fail. 2021 Jan;27(1):20-28. doi: 10.1016/j.cardfail.2020.06.016. Epub 2020 Jul 9.

  PMID: 32652246 BACKGROUND

• Ter Maaten JM, Dauw J, Martens P, Somers F, Damman K, Metalidis C, Nijst P, Dupont M, Mullens W. The Effect of Decongestion on Intrarenal Venous Flow Patterns in Patients With Acute Heart Failure. J Card Fail. 2021 Jan;27(1):29-34. doi: 10.1016/j.cardfail.2020.09.003. Epub 2020 Sep 11.

  PMID: 32927066 BACKGROUND

• Fujii K, Nakayama I, Izawa J, Iida N, Seo Y, Yamamoto M, Uenishi N, Terasawa T, Iwata M. Association between intrarenal venous flow from Doppler ultrasonography and acute kidney injury in patients with sepsis in critical care: a prospective, exploratory observational study. Crit Care. 2023 Jul 10;27(1):278. doi: 10.1186/s13054-023-04557-9.

  PMID: 37430356 BACKGROUND

• Fan J, Upadhye S, Worster A. Understanding receiver operating characteristic (ROC) curves. CJEM. 2006 Jan;8(1):19-20. doi: 10.1017/s1481803500013336. No abstract available.

  PMID: 17175625 BACKGROUND

• Macedo E, Bouchard J, Soroko SH, Chertow GM, Himmelfarb J, Ikizler TA, Paganini EP, Mehta RL; Program to Improve Care in Acute Renal Disease Study. Fluid accumulation, recognition and staging of acute kidney injury in critically-ill patients. Crit Care. 2010;14(3):R82. doi: 10.1186/cc9004. Epub 2010 May 6.

  PMID: 20459609 BACKGROUND

• Vaara ST, Korhonen AM, Kaukonen KM, Nisula S, Inkinen O, Hoppu S, Laurila JJ, Mildh L, Reinikainen M, Lund V, Parviainen I, Pettila V; FINNAKI Study Group. Fluid overload is associated with an increased risk for 90-day mortality in critically ill patients with renal replacement therapy: data from the prospective FINNAKI study. Crit Care. 2012 Oct 17;16(5):R197. doi: 10.1186/cc11682.

  PMID: 23075459 BACKGROUND

• Maluangnon C, Saokaew A, Rojwatcharapibarn S, Ratanarat R. Intrarenal venous flow patterns and their association with successful fluid removal in critically ill patients: a prospective observational exploratory study. Ultrasound J. 2025 Oct 6;17(1):44. doi: 10.1186/s13089-025-00447-z.

  PMID: 41051454 DERIVED

MeSH Terms

Conditions

Critical Illness; Edema

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Ranistha Ratanarat, MD

  Division of Critical Care, Department of Medicine, Siriraj Hospital, Mahidol University

  PRINCIPAL INVESTIGATOR

• Apatsara Saokaew, MD

  Division of Critical Care, Department of Medicine, Siriraj Hospital, Mahidol University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 22, 2024
• Study Start: January 23, 2024
• Primary Completion: September 16, 2024
• Study Completion: October 13, 2024
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: All IPD will become available starting briefly following a publication of the study with no end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by institutional review board or ethical committee.

Locations

TH (1)