Clinical Effects of Ringers Lactate Versus Sterofundin/ Plasmalyte Solution in Patients With Sepsis

Официальное название

Clinical Effects of Ringers Lactate Versus Sterofundin/Plasmalyte Solution in Surgical Adult Patients With Sepsis; a Comparative Study in ICU Patients

Обзор

The goal of this clinical trial is to compare the clinical effects of using Ringer's Lactate and Sterofundin/ Plasmalyte as maintenance fluids in adult patients who have undergone abdominal surgery and are septic. The primary outcome will be the change in serum lactate levels. Secondary outcomes will include renal function parameters, qSOFA scores, and the incidence of postoperative complications within the first 72 hours following surgery.

Подробное описание

The goal of this clinical trial is to compare the clinical effects of using Ringer's Lactate and Sterofundin/PlasmaLyte as maintenance fluids in adult patients who have undergone abdominal surgery and are septic.

The primary outcome will be the change in serum lactate levels. Secondary outcomes will include renal function parameters, qSOFA scores, and the incidence of postoperative complications within the first 72 hours following surgery.

The main questions it aims to answer are:

1. Does the choice of fluid produce different outcomes in this patient population? 2. If yes, then which fluid produces better outcomes?

Enrolled patients will be randomly assigned Ringer's Lactate or Sterofundin for intravenous infusion. The volume, infusion rate and additive content will be determined by the treating clinicians. The intervention will last for 72 hours after patients' enrolment.

Вмешательства

• Другое Ringer's Lactate Crystalloid Solutions
  A balanced crystalloid solution containing sodium, potassium, calcium, chloride, and lactate as a buffer. Used at a standard maintenance rate for adult postoperative patients.
• Другое Sterofundin (Bolus of crystalloids)
  A balanced, multi-electrolyte crystalloid solution containing acetate and malate as buffers instead of lactate. Designed to more closely match plasma electrolyte composition, with a lower chloride concentration than RL.

Первичные конечные точки

• serum lactate [Срок оценки: Samples will be collected at baseline (preoperatively or immediately postoperatively) and at predefined intervals during the postoperative period (e.g., 24 and 48 hours after surgery).]

Критерии участия

Критерии включения

• Underwent Abdominal Surgery and postoperative length of stay is more than 24 hours
• ASA 1 to 4
• Diagnosis of sepsis (qSOFA score 2 or more)

Критерии исключения

• Patients with Renal failure/hepatic failure/severe metabolic acidosis
• Patients requiring renal replacement therapy prior to enrolment
• Patients with suspected poisoning
• Pregnant women
• Patients having solitary kidney

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Combined Military Hospital Lahore — Lahore

Идентификаторы

NCT: NCT07239713 · 563/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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