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Strong Albumin Solutions in Patients With Septic Shock (SWIPE2)

Primary Purpose

Sepsis, Septic Shock, Shock, Toxic

Status
Not yet recruiting
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
hyperoncotic human albumin solution
Buffered crystalloid solutions
Sponsored by
Manchester University NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring sepsis, septic shock, fluid therapy, hyperoncotic albumin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Suspected or documented infection
  2. Organ dysfunction defined as SOFA score ≥2
  3. Need for vasopressor infusion for ≥2 hours
  4. Serum lactate ≥2 mmol/L
  5. Eligible for critical care admission without any restrictions

Exclusion Criteria:

  1. >24 hours since the time point of meeting all inclusion criteria
  2. <18 years of age
  3. Pregnancy
  4. Patients with a known allergy to albumin
  5. Jehova's witnesses or other patients expressing a known objection to the use of blood products
  6. Previous receipt of human albumin solution for the episode of sepsis in question
  7. Previous enrolment in this study

Sites / Locations

  • Manchester Royal Infirmary
  • Wythenshawe Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hyperoncotic albumin

Buffered crystalloids

Arm Description

Hyperoncotic albumin for all fluid resuscitation and also as a daily supplement, guided by daily serum albumin values, for up to 7 days.

Buffered crystalloid solutions for all fluid resuscitation and maintenance purposes. Participants in this arms will NOT receive any albumin during their participation.

Outcomes

Primary Outcome Measures

Participant recruitment rate
Evidence to confirm feasibility of the study protocol without any further modification for a future efficacy trial. This will be objectively determined by a recruitment rate of >2 participants per month, resulting in study recruitment being completed within 24 months of opening the trial. A pre-specified threshold of >80% of the anticipated recruitment rate would support the feasibility of a future efficacy trial.

Secondary Outcome Measures

Vasopressor use
The hourly use of vasopressor infusions from enrolment in mcg/kg/min
Survival
Number of participants who survive
Healthcare costs
Healthcare service use and costs. These will be estimated using a participant's medical records to estimate the cost of their hospital admission episode. Data on further healthcare costs will be acquired through the 90-day follow-up where participants will be asked about the healthcare service use since their discharge from hospital. All costs will be calculated in £GBP, with current equivalents in Euros and USD.
Quality of Life of study participants
Healthcare related quality of life as measured by the EuroQol Research Foundation's EQ-5D-5L questionnaire via telephone. This widely validated tool assesses healthcare related quality of life across 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each domain is scored across 5 levels, with 1 indicating 'no problems' and 5 indicating 'unable to/extreme problems'. The questionnaire also includes a self-reported health score using a visual analogue scale. This EQ-VAS derives a total health score from 0 to 100, with 100 indicating the best health a participant can imagine, and 0 indicating the worst heath imaginable.
Cumulative fluid balance (in millilitres)
This daily measure of total fluid administered minus total fluid out reflects the daily amount of fluid accumulated by participants. It will be measured on a daily basis with summary comparisons made at day 7.

Full Information

First Posted
December 13, 2021
Last Updated
September 4, 2023
Sponsor
Manchester University NHS Foundation Trust
Collaborators
University of Manchester
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1. Study Identification

Unique Protocol Identification Number
NCT05208242
Brief Title
Strong Albumin Solutions in Patients With Septic Shock
Acronym
SWIPE2
Official Title
Small Volume Fluid Resuscitation and Supplementation With 20% albumIn Versus Buffered Crystalloids in PatiEnts With Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Manchester University NHS Foundation Trust
Collaborators
University of Manchester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Sepsis is an increasingly recognised burden to healthcare systems worldwide. Intravenous fluid therapy is a common first-line intervention recommended by international guidelines. Hyperoncotic preparations of human albumin solution are widely available, but their efficacy has yet to be proven. This randomised feasibility trial will test whether it is feasible to administer hyperoncotic albumin solutions as both fluid resuscitation and as a regular supplement in patients with early septic shock.
Detailed Description
Background to this research Sepsis is the most severe type of infection. It happens when a patient's own immune system is trying to fight an infection, but causes damage or even failure to vital organs such as the heart, lungs or kidneys. It is a life-threatening condition and even with prompt treatment as many as 1 in 4 patients with sepsis don't survive. Septic shock is a term used to describe the worst form of sepsis, where patients need life-supporting treatments in intensive care. Guidelines recommend doctors give fluid to patients with sepsis. This aims to improve blood flow to vital organs and reduce the risk of further damage. However, there maybe risks if patients are given too much fluid, such as developing kidney failure or even death. Human albumin solution is a type of fluid, made from blood donated by healthy volunteers. Albumin has been used safely for many years but is more expensive compared to other fluids. Alternative fluids include solutions of salts and water that closely match the contents of human blood. Some research suggests patients with sepsis might benefit from being given albumin, particularly those with septic shock, but doctors remain unsure on whether they should give it to patients with sepsis, or whether the additional expense is worthwhile. The overall aims of this research The aim of this research is to test whether it is possible to give patients with early septic shock strong solutions of albumin when they arrive in intensive care. The investigators will also begin to explore the financial costs of using albumin and whether they can be justified for patients treated in the NHS. What will happen in this research? The investigators will conduct a study of 50 patients who are admitted to intensive care with septic shock. Patients will be randomly divided into two groups. One group will receive albumin and the other standard salt solutions. Participating patients will provide blood and urine samples shortly after their arrival in intensive care and also 2 and 5 days later. All other aspects of care and treatment will remain the same. Patients will be observed and followed up to see how they are 6 months after entering the study. What will happen with the results? The findings of this research will be published in a medical journal and presented at meetings where other healthcare providers can hear of our work. Every participating patient will receive a written summary of the study results. Most importantly, the results of this study will help us move forward with further research into how albumin maybe used cost-effectively in patients with sepsis in the NHS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Septic Shock, Shock, Toxic
Keywords
sepsis, septic shock, fluid therapy, hyperoncotic albumin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A multi-centre, randomised, open-label, feasibility study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperoncotic albumin
Arm Type
Experimental
Arm Description
Hyperoncotic albumin for all fluid resuscitation and also as a daily supplement, guided by daily serum albumin values, for up to 7 days.
Arm Title
Buffered crystalloids
Arm Type
Active Comparator
Arm Description
Buffered crystalloid solutions for all fluid resuscitation and maintenance purposes. Participants in this arms will NOT receive any albumin during their participation.
Intervention Type
Drug
Intervention Name(s)
hyperoncotic human albumin solution
Intervention Description
20% human albumin solution (presented in 100ml glass bottles)
Intervention Type
Drug
Intervention Name(s)
Buffered crystalloid solutions
Other Intervention Name(s)
Hartmann's solution, Compound Sodium Lactate
Intervention Description
Buffered crystalloids solutions for all intravenous fluid therapy
Primary Outcome Measure Information:
Title
Participant recruitment rate
Description
Evidence to confirm feasibility of the study protocol without any further modification for a future efficacy trial. This will be objectively determined by a recruitment rate of >2 participants per month, resulting in study recruitment being completed within 24 months of opening the trial. A pre-specified threshold of >80% of the anticipated recruitment rate would support the feasibility of a future efficacy trial.
Time Frame
24 months after opening the trial
Secondary Outcome Measure Information:
Title
Vasopressor use
Description
The hourly use of vasopressor infusions from enrolment in mcg/kg/min
Time Frame
hourly values for up to 7-days
Title
Survival
Description
Number of participants who survive
Time Frame
90-days after enrolment
Title
Healthcare costs
Description
Healthcare service use and costs. These will be estimated using a participant's medical records to estimate the cost of their hospital admission episode. Data on further healthcare costs will be acquired through the 90-day follow-up where participants will be asked about the healthcare service use since their discharge from hospital. All costs will be calculated in £GBP, with current equivalents in Euros and USD.
Time Frame
90-days after enrolment
Title
Quality of Life of study participants
Description
Healthcare related quality of life as measured by the EuroQol Research Foundation's EQ-5D-5L questionnaire via telephone. This widely validated tool assesses healthcare related quality of life across 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each domain is scored across 5 levels, with 1 indicating 'no problems' and 5 indicating 'unable to/extreme problems'. The questionnaire also includes a self-reported health score using a visual analogue scale. This EQ-VAS derives a total health score from 0 to 100, with 100 indicating the best health a participant can imagine, and 0 indicating the worst heath imaginable.
Time Frame
90-days after enrolment
Title
Cumulative fluid balance (in millilitres)
Description
This daily measure of total fluid administered minus total fluid out reflects the daily amount of fluid accumulated by participants. It will be measured on a daily basis with summary comparisons made at day 7.
Time Frame
daily values for up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suspected or documented infection Organ dysfunction defined as SOFA score ≥2 Need for vasopressor infusion for ≥2 hours Serum lactate ≥2 mmol/L Eligible for critical care admission without any restrictions Exclusion Criteria: >24 hours since the time point of meeting all inclusion criteria <18 years of age Pregnancy Patients with a known allergy to albumin Jehova's witnesses or other patients expressing a known objection to the use of blood products Previous receipt of human albumin solution for the episode of sepsis in question Previous enrolment in this study
Facility Information:
Facility Name
Manchester Royal Infirmary
City
Manchester
State/Province
Lancashire
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Bannard-Smith, MB ChB
Phone
01612764712
Email
j.bannardsmith@mft.nhs.uk
Facility Name
Wythenshawe Hospital
City
Manchester
State/Province
Lancashire
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim Felton
Email
Tim.Felton@mft.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No

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Strong Albumin Solutions in Patients With Septic Shock

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