NCT04759989

Brief Summary

To explore the safety and feasibility of alternative fluid resuscitation strategies in obese patients with septic shock.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable sepsis

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable sepsis

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2022

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

February 10, 2021

Last Update Submit

August 10, 2022

Conditions

SepsisSeptic ShockObesity

Outcome Measures

Primary Outcomes (4)

  • Feasibility1: fluid target

    percentage of of patients with actual volume received within 10% of target fluid volume.

    3 hours

  • Safety-ventilation

    Proportion of patients requiring invasive or noninvasive mechanical ventilation

    24 hours

  • Safety-vasopressors

    proportion of patients requiring vasopressor administration

    24 hours

  • Safety-time to hemodynamic stability

    time from randomization to map \>65 without use of vasopressors and no lactate \>2

    72 hours

Secondary Outcomes (5)

  • Exploratory: in-hospital all cause mortality

    28 days

  • Exploratory: ICU length of stay

    28 days

  • feasibility2: recruitment rate

    study duration

  • feasibility3: time to randomization

    3 hours

  • Exploratory: hospital length of stay

    28 days

Study Arms (3)

30cc/kg ideal body weight (IBW)

ACTIVE COMPARATOR

30cc/kg intravenous fluids based on the patients calculated ideal body weight will be administered when randomized to this arm Using Devine's formula. (men: 50kg + 2.3kg \* (height(in) - 60); women: 45.5kg + 2.3kg \* (height(in) - 60)

Procedure: Ideal Body Weight Dosing

30cc/kg adjusted body weight (AdjBW)

ACTIVE COMPARATOR

30cc/kg intravenous fluids based on the patients calculated adjusted body weight will be administered when randomized to this arm Calculated by the following formula: AdjBW = IBW + 0.4(ABW - IBW).

Procedure: Adjusted Body Weight Dosing

30cc/kg actual body weight (ABW)

ACTIVE COMPARATOR

30cc/kg intravenous fluids based on the patients actual body weight will be administered when randomized to this arm Patients will receive an initial fluid bolus of 30 cc/kg of actual body weight

Procedure: Actual Body Weight Dosing

Interventions

Actual Body Weight DosingPROCEDURE

30cc/kg initial bolus calculated using Actual Body Weight

30cc/kg actual body weight (ABW)
Adjusted Body Weight DosingPROCEDURE

30cc/kg initial bolus calculated using Adjusted Body Weight

30cc/kg adjusted body weight (AdjBW)
Ideal Body Weight DosingPROCEDURE

30cc/kg initial bolus calculated using Ideal Body Weight

30cc/kg ideal body weight (IBW)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • BMI \> 30
  • suspected infection, and either:
  • hypotension (a systolic blood pressure \< 90mmHg) or
  • blood lactate concentration \> 4mmol/L

You may not qualify if:

  • Pregnant
  • Primary diagnosis of acute cerebral vascular event
  • Acute coronary syndrome
  • Acute pulmonary edema
  • Status asthmaticus
  • Major cardiac arrhythmia
  • Active gastrointestinal hemorrhage
  • Seizures
  • Drug overdose
  • Burns or trauma
  • Requirement for immediate surgery
  • CD4\<50/mm3
  • Do-not-resuscitate order status
  • Transferred from another hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Related Publications (6)

  • Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Crit Care Med. 2017 Mar;45(3):486-552. doi: 10.1097/CCM.0000000000002255.

    PMID: 28098591BACKGROUND

  • Wacharasint P, Boyd JH, Russell JA, Walley KR. One size does not fit all in severe infection: obesity alters outcome, susceptibility, treatment, and inflammatory response. Crit Care. 2013 Jun 20;17(3):R122. doi: 10.1186/cc12794.

    PMID: 23786836BACKGROUND

  • Arabi YM, Dara SI, Tamim HM, Rishu AH, Bouchama A, Khedr MK, Feinstein D, Parrillo JE, Wood KE, Keenan SP, Zanotti S, Martinka G, Kumar A, Kumar A; Cooperative Antimicrobial Therapy of Septic Shock (CATSS) Database Research Group. Clinical characteristics, sepsis interventions and outcomes in the obese patients with septic shock: an international multicenter cohort study. Crit Care. 2013 Apr 17;17(2):R72. doi: 10.1186/cc12680.

    PMID: 23594407BACKGROUND

  • Boyd JH, Forbes J, Nakada TA, Walley KR, Russell JA. Fluid resuscitation in septic shock: a positive fluid balance and elevated central venous pressure are associated with increased mortality. Crit Care Med. 2011 Feb;39(2):259-65. doi: 10.1097/CCM.0b013e3181feeb15.

    PMID: 20975548BACKGROUND

  • Marik PE, Linde-Zwirble WT, Bittner EA, Sahatjian J, Hansell D. Fluid administration in severe sepsis and septic shock, patterns and outcomes: an analysis of a large national database. Intensive Care Med. 2017 May;43(5):625-632. doi: 10.1007/s00134-016-4675-y. Epub 2017 Jan 27.

    PMID: 28130687BACKGROUND

  • Taylor SP, Karvetski CH, Templin MA, Heffner AC, Taylor BT. Initial fluid resuscitation following adjusted body weight dosing is associated with improved mortality in obese patients with suspected septic shock. J Crit Care. 2018 Feb;43:7-12. doi: 10.1016/j.jcrc.2017.08.025. Epub 2017 Aug 15.

    PMID: 28823951BACKGROUND

MeSH Terms

Conditions

SepsisShock, SepticObesity

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and Symptoms

Study Officials

  • Brice Taylor, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 18, 2021

Study Start

June 1, 2021

Primary Completion

April 25, 2022

Study Completion

May 25, 2022

Last Updated

August 15, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)