How to judge for fluids in collapsed patients with severe infection
| ISRCTN | ISRCTN22435678 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22435678 |
- Submission date
- 03/11/2021
- Registration date
- 30/11/2021
- Last edited
- 30/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
Severe infections cause a condition called sepsis. More severe cases start to collapse and require prompt actions. These actions include fluid infusions to maintain organs. The aim of this study is to find out whether the amount of fluid given to collapsed patients with sepsis should be driven by the results of testing, or whether it should be kept as low as possible.
Who can participate?
Patients aged 18 years and over with severe sepsis
What does the study involve?
Participants are randomly allocated to the infusion of fluids according to the results of tests, or to low fluid infusion.
What are the possible benefits and risks of participating?
The possible benefits are keeping organs perfused to improve outcomes. The risks include excessive fluid administration or under-infusion.
Where is the study run from?
Cairo University Hospital (Egypt)
When is the study starting and how long is it expected to run for?
February 2018 to January 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Walid Mohamed Kamel
walidkamel@cu.edu.eg
Contact information
Public
Meerag City, Carrefour Maadi
7110
Cairo
11436
Egypt
 ORCID ID |
0000-0003-0248-9498 |
|---|---|
| Phone | +20 (0)1111632486 |
| walidkamel@cu.edu.eg |
Study information
| Study design | Prospective interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet. This sheet is in Arabic. |
| Scientific title | Dynamic testing based versus restrictive based fluid administration following early fluid resuscitation in septic shock patients: a pilot study |
| Study objectives | It is hypothesized that the restrictive fluid protocol was comparable in terms of mortality to the dynamic-based testing for fluid responsiveness protocol, following initial fluid resuscitation in septic shock patients. Secondary outcomes were length of ICU stay, mechanical ventilation and need for dialysis. |
| Ethics approval(s) | Approved 25/02/2018, Critical Care Department, Faculty of Medicine, Cairo University (El Sarayat st., Manial, Cairo, 11562, Egypt; +2 (0)122 7434 117; shereenelgengehy@gmail.com), ref: not applicable |
| Health condition(s) or problem(s) studied | Septic shock |
| Intervention | This is a prospective cohort study, recruiting septic shock patients, conducted in the Critical Care Department, Cairo University. All patients are initially resuscitated. Patients are assigned according to physician discretion to the restrictive group (fluid administration with a predetermined rate of 1 ml/kg/hour), or the dynamic-based testing group (fluid administration according to dynamic measures, following the passive leg raising method). A positive response is considered when cardiac output increases by 10%. |
| Intervention type | Other |
| Primary outcome measure | Mortality measured through documenting mortality cases daily during the whole ICU stay |
| Secondary outcome measures | Measured during the whole ICU stay: 1. ICU length of stay measured through reviewing patient notes 2. Need for renal replacement therapy recorded on a daily basis through daily endorsement sheets and nursing documentation 3. Need for respiratory support recorded on a daily basis through daily endorsement sheets and nursing documentation 4. Need for vasopressors recorded on a daily basis through daily endorsement sheets and nursing documentation |
| Overall study start date | 25/02/2018 |
| Completion date | 31/01/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Total final enrolment | 80 |
| Key inclusion criteria | 1. Patients ≥18 years old 2. Diagnosed with septic shock (sepsis with persisting hypotension despite adequate volume resuscitation and/or having a serum lactate level >4 mmol/l (18 mg/dl) requiring vasopressors to maintain mean arterial pressure ≥65 mmHg) |
| Key exclusion criteria | 1. Patients aged under 18 years 2. Refusal to consent 3. Conditions that could affect lactate clearance e.g., hepatic, or renal impairment 4. Alcoholic patients |
| Date of first enrolment | 01/11/2019 |
| Date of final enrolment | 30/06/2020 |
Locations
Countries of recruitment
- Egypt
Study participating centre
Faculty of Medicine
El Saraya Street
Manyal
Cairo
11562
Egypt
Sponsor information
University/education
Critical Care Department
Faculty of Medicine
El Saraya Street
Manyal
Cairo
11956
Egypt
| Phone | +20 (0)122 743 4117 |
|---|---|
| shereenelgengeehy@gmail.com | |
| Website | https://medicine.cu.edu.eg/index.php/en/ |
"ROR" |
https://ror.org/03q21mh05 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/01/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study are/will be available upon request from Dr Walid Mohamed Kamel (walidkamel@cu.edu.eg). Data would be available after publication for 6 months, including data collected during patient evaluation and consents obtained. |
Editorial Notes
05/11/2021: Trial's existence confirmed by Cairo University.
