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A study to observe the effect of a protocolized removal of excess fluid on the integrity of small blood vessel lining in patients with sepsis

Effect of Protocolized De-resuscitation on Endothelial Glycocalyx Degradation Products in Critically Ill Adult Patients with Sepsis: A prospective observational study effect of protocol - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/09/093958
Enrollment
70
Registered
2025-09-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A419- Sepsis, unspecified organism

Interventions

Intervention1: Nil: Nil

Sponsors

research section, AIIMS, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Critically ill patients with sepsis and septic shock, mechanically ventilated patients with iatrogenic volume overload requiring de-resuscitation. Volume overload will be identified by cumulative positive fluid balance of more than 10 percent body weight and / or by clinical signs of fluid overload like in lungs (chest Xray, lung ultrasound ), venous excess ultrasound grade more than 0, of will be included.

Exclusion criteria

Exclusion criteria: 1. Refusal to participate 2. Pregnancy or post- partum up to 6 weeks 3. Patients who are requiring vasopressor/ inotrope more than norepinephrine dose of 0.2 micrograms per kg per min or equivalent doses. 4. Hypernatremia more than 155 meq/L 5. Receiving renal replacement therapy 6. Patients with medical conditions like diabetic ketoacidosis, hyperosmolar hyperglycemic states, nontraumatic subarachnoid hemorrhage. 7. Acute cardiogenic shock 8. Known allergy to the drugs used

Design outcomes

Primary

MeasureTime frame
to compare serum hyaluronan level before and after ?protocolized de-resuscitation? in critically ill mechanically ventilated adult patients with iatrogenic volume overloadTimepoint: Day 3—

Secondary

MeasureTime frame
1. To compare syndecan-1, VE- Cadherin, bio- adrenomedullin and heparan sulphate level before and after ?protocolized de-resuscitation?. 2. To compare ESR & C- reactive protein level before and after ?protocolized de-resuscitation?. 3. To compare serum albumin level before and after ?protocolized deresuscitation?. 4. To compare serum urea and creatine before and after ?protocolized deresuscitation?. 5. To know the association between change in glycocalyx degradation product and intensive care unit stay since recruitment in this study. 6. To know the association between change in glycocalyx degradation product and negative fluid balance since recruitment in this study. Timepoint: Day 3; 7. To know the association between change in glycocalyx degradation product and survival to ICU dischargeTimepoint: Upto day 30—

Countries

India

Contacts

Public ContactDr Sulagna Bhattacharjee

AIIMS, New Delhi

bhattacharjee.sulagna85@gmail.com01126593212

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026